Major Safety Alerts inFebruary 2009 (This page is subject to further

Major Safety Alerts inFebruary 2009 (This page is subject to further review) The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the summary of February 2009 and more details will be provided when available *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Source of Date of Issue Agent Contact MDCO Ref. No. Description of Product Reference No. by Source Alert Type by Source Local Agent Information* (YYYY/MM/DD) Telephone No. Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor Medtronic International, Ltd. N.A. Firm Initiated Field Action 2009/02/02 Medtronic Internation, Ltd. 2919 1300 Monthly Summary of Medical Device Safety Alerts - January 2009 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue MDCO Ref. Source of Local Agent Description of Product Reference No. by Source Alert Type by Source (YYYY/MM/DD) No. Information* SN090101 Terumo Advanced Perfusion System 1 (Model 801763 and 801764) Z-0445-2009 to Z-0446-2009 Class II 2009/01/02 TERUMO CHINA (H.K.) LTD. FDA CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel SN090102 Z-0476-2009 Class II 2009/01/02 Boston Scientific Hong Kong Ltd FDA Harvesting System with VASOVIEW Flexible Endoscopic Tools FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66Z-0486-2009 Class II 2009/01/02 N.A. SN090103 FDA FA-SF) Smiths Medical Wallace Oocyte Recovery Needles, Oocyte Z-0593-2009 Class II 2009/01/02 Gold Pacific Enterprises SN090104 FDA Recovery sets (Product no. ONS1633LL-750 and ONS1733LL-750) SN090105 SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) Z-0524-2009 Class II 2009/01/02 Siemens Healthcare Diagnostic Limited FDA SN090106 Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025) Z-0480-2009 Class II 2009/01/02 N.A. FDA SN090107 Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001) Z-0500-2009 Class II 2009/01/02 N.A. FDA Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation SN090108 2008/011/028/061/020 FSCA 2009/01/07 Stryker China Ltd MHRA Chair Model 6253 SN090109 Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II 2008/012/009/061/007 FSCA 2009/01/07 Johnson & Johnson Medical (HK) MHRA SN090110 ArthroCare Saber 30 with Integrated Cable Wand 2008/012/009/061/003 FSCA 2009/01/08 N.A. MHRA EV3 Marathon Flow Directed Micro Catheter Catalog Number 105SN090111 2008/012/009/061/015 FSCA 2009/01/08 N.A. MHRA 5055 SN090112 GE Centricity Ultra Laboratory System Software Z-0472-2009 Class II 2009/01/08 GE Medical Systems Hong Kong Ltd. FDA SN090113 Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace Z-0543-2009 to Z-0545-2009 Class II 2009/01/08 Siemens Healthcare Diagnostic Limited FDA SN090114 Alphatec Spine Novel PEEK VBR XS Z-0507-2009 to Z-0508-2009 Class II 2009/01/08 N.A. FDA SN090115 Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K Z-0604-2009 Class II 2009/01/08 N.A. FDA SN090116 Stryker Leibinger New Generation/Universal Mandibular System Z-0610-2009 Class II 2009/01/08 Stryker China Ltd FDA SN090117 Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator Z-0617-2009 Class II 2009/01/08 N.A. FDA CovaTec Flexi-Seal Fecal Management System Advanced Odor SN090118 Z-0618-2008 Class II 2009/01/08 N.A. FDA Control Kit. Rx only SN090119 Edwards Lifesciences EndoClamp aortic catheter Z-0644-2009 to Z-0645-2009 Class II 2009/01/08 N.A. FDA SN090120 Hyphen BioMed Biophen Heparin 6 (various lots) 2008/012/003/061/001 FSCA 2009/01/09 N.A. MHRA SN090121 Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay 2008/012/023/051/001 FSCA 2009/01/09 Siemens Healthcare Diagnostic Limited MHRA SN090122 Arcomedical Infusion Syramed SP6000 Syringe Pumps 2008/011/005/601/004 FSCA 2009/01/09 N.A. MHRA Boston Scientific SN090123 Boston Scientific Safety and Standard Push PEG Kits N.A. Firm Initiated Field Action 2009/01/13 Boston Scientific Hong Kong Ltd Hong Kong Ltd Zimmer NexGen® Complete Knee Solution Provisional Articular SN090124 2008/012/016/061/007 FSCA 2009/01/14 Zimmer PTE Ltd. (Hong Kong branch) MHRA Surface SN090125 ThermoFisher BO0366G Brain heart infusion, lot number 1070312 2008/012/015/601/005 FSCA 2009/01/14 N.A. MHRA GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP SN090126 Z-0341-2009 to Z-0342-2009 Class II 2009/01/14 GE Medical Systems Hong Kong Ltd. FDA Fluoroscopic x-Ray System Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and SN090127 Z-0439-2009 to Z-0440-2009 Class II 2009/01/14 N.A. FDA RL 01 SN090128 Innovative Implant Sinu-Lift System (Model SLS-1) Z-0505-2009 Class II 2009/01/14 N.A. FDA SN090129 Biomet Compress Instrument Anchor Plug Holders Z-0517-2009 to Z-0521-2009 Class II 2009/01/14 N.A. FDA Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared SN090130 Z-0600-2009 to Z-0603-2009 Class II 2009/01/14 N.A. FDA and Pro 2000 Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no Z-0542-2009 Class II 2009/01/14 Roche Diagnostics (Hong Kong) Ltd SN090131 FDA 04522320190) SN090132 GE Solar 8000M System Z-0285-2009 Class II 2009/01/14 GE Medical Systems Hong Kong Ltd. FDA SN090133 Siemens CT syngo Dual Energy Viewer (Model 10094833) Z-0647-2009 Class II 2009/01/14 Siemens Healthcare Diagnostic Limited FDA SN090134 Hitachi CXR4 Computed Tomography Scanner Z-0608-2009 Class II 2009/01/14 N.A. FDA ACIST CVi Angiographic Injection System (Model: CVi Toshiba SN090135 Z-0643-2009 Class II 2009/01/14 N.A. FDA interface Cable) SN090136 Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX) Z-0607-2009 Class II 2009/01/14 N.A. FDA Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate SN090137 Z-0871-2009 Class II 2009/01/14 Zimmer PTE Ltd. (Hong Kong branch) FDA (Ref 6420-01-230) SN090138 Frontier Medical Repose Mattress and Cushion 2008/009/015/301/001 FSCA 2009/01/15 N.A. MHRA Medical Device Control Office 2 Agent Contact Telephone No 2866 0811 2960 7136 N.A. 2544 2602 2810 7533 N.A. N.A. 2518 6915 2738 6027 N.A. N.A. 2783 1838 2810 7533 N.A. N.A. 2518 6915 N.A. N.A. N.A. N.A. 2810 7533 N.A. 2960 7136 2992 0968 N.A. 2783 1838 N.A. N.A. N.A. N.A. 2485 7510 2783 1838 2810 7533 N.A. N.A. N.A. 2992 0968 N.A. Department of Health The Government of HKSAR SN090139 SN090140 SN090141 SN090142 SN090143 SN090144 SN090145 SN090146 SN090147 SN090148 SN090149 SN090150 SN090151 SN090152 SN090153 SN090154 SN090155 SN090156 SN090157 SN090158 SN090159 SN090160 SN090161 SN090162 SN090163 SN090164 SN090165 SN090166 SN090167 SN090168 SN090169 SN090170 SN090171 SN090172 SN090173 SN090174 SN090175 SN090176 SN090177 SN090178 SN090179 SN090180 SN090181 SN090182 Boston Scientific Stonetome Single-Use Stone Removal Device Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000000), Intouch Bed Model 2140 with Positionpro (model: 2140-000Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation Kit, C) 1.5/IMF Small Office Set Toshiba Aquilion One (TSX-310A/2) Invacare Careguard Mattress Medtronic DLP Pericardial / Intracardiac Sump Philips Easydiagnost Eleva Convatec Flexi-Seal FMS Advanced Odor Control KCI Kinair IV Maquet Maquet Foot Paddle Philips Multi Diagnostic Eleva-Flat Detector-IM Stryker Patient Registration Mask (Box of 5) Coloplast Philips Bougle Roche Diagnostics Process System Manager Smith & Nephew Reflection Hip PE Inlay (7174-0250) Synthes (Canada) Synfix LR, Low Profile U-Joint Driver KCI Therapulse ATP Biomerieux Vitek 2 GN Card Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12) Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris H5000C Cardiology Imaging System (722016), D) Integris Allura (722043*), E) Allura XPER FD10, F) Allura XPER FD20 Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology Imaging System (722016), C) Integris Allura (722043*), D) Allura XPER FD10, E) Allura XPER FD20 System Stryker A)Intouch Critical Care Bed Model 2130 (2130-000-000), B) Intouch critical Care Bed Model 2140 (2140-000-000) St Jude Medical Epicor LP Connecting Cable BioMerieux Vironostika HIV Uni-Form II Ag/Ab Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units) Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes) ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903 Ortho Solutions FPS Locking Screws (14mm/18ms) ThermoFisher TPHA Test Kit BioMerieux Chocolate PolyViteX VCAT3 agar Diagnostica Stago STA - Cuvettes Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H4902 Smiths Medical BCI 9200 Advisor Vital Signs Monitor CMS Software 4.3.1 through 4.40.00 Sorin Mini Bypass Bag Days Healthcare Walking frame Olympus PK7300 blood grouping system Siemens Sentinel Apolipoprotein B Otto Bock Blizzard Active Wheelchair Bausch & Lomb Akreos Advanced Optics Aspheric Lens Maquet SERVO 300A Automode Philips Pulmonary Toolkit Medtronic MicroTargetingTM Drive System and Accessories Medical Device Control Office Boston Scientific Hong Kong Ltd N.A. Firm Initiated Field Action 2009/01/15 Boston Scientific Hong Kong Ltd 2960 7136 Health Canada 45354 Type II 2009/01/15 Stryker China Ltd 2518 6915 Health Canada 43740 Type II 2009/01/15 N.A. N.A. Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada 44879 45093 45468 45433 45051 45500 44983 44908 45115 45314 44820 45263 45120 44999 44650 Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II Type II 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 2009/01/15 Sanko Medical Systems (HK) LTD Direct Health LTD Medtronic International, Ltd. Philips Health Care (Great China) Bristol-Myers Squibb (HK) LTD. N.A. Maquet Hong Kong LTD. Philips Health Care (Great China) Stryker China Ltd Coloplast (HK) LTD Roche Diagnostics (Hong Kong) Ltd Smith & Nephew LTD Synthes International Ltd. N.A. Biomerieux China Ltd. (HK office) 238400688 N.A. 2919 1300 2821 5480 2510 6146 N.A. 2393 9511 2821 5480 2518 6915 3628 7427 2485 7510 2648 7700 N.A. N.A. 2356 7033 Health Canada 44757 Type II 2009/01/15 Abbott Laboratories LTD. 2593 2211 Health Canada 44817 Type II 2009/01/15 Philips Health Care (Great China) 2821 5480 Health Canada 45310 Type II 2009/01/15 Philips Health Care (Great China) 2821 5480 Health Canada 45351 Type II 2009/01/15 Stryker China Ltd 2518 6915 MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA 2008/012/010/061/001 2008/011/019/061/001 2008/010/002/401/007 2008/012/001/061/004 2008/012/002/291/002 2008/012/015/601/004 2008/010/017/401/001 2008/012/022/051/001 2008/012/001/601/001 2008/012/030/291/017 2008/012/022/601/003 2008/012/030/061/006 2008/012/012/601/004 2008/012/031/061/002 2008/010/007/401/016 2008/012/023/051/002 2009/001/005/061/005 2008/012/029/301/002 2008/012/019/291/002 2008/012/016/061/001 2008/012/029/291/001 2008/012/030/291/011 FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/20 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/21 2009/01/22 2009/01/22 N.A. Biomerieux China Ltd. (HK office) N.A. Siemens Healthcare Diagnostic Limited Goodman Medical Supplies Ltd N.A. N.A. N.A. Biomerieux China Ltd. (HK office) Healthpro Technology Co. Ltd Abbott Laboratories LTD. Goodman Medical Supplies Ltd N.A. N.A. N.A. Olympus Hong Kong and China Limited Siemens Healthcare Diagnostic Limited N.A. Bausch & Lomb (Hong Kong ) Ltd Maquet Hong Kong LTD. Philips Health Care (Great China) Medtronic International, Ltd. N.A. 2356 7033 N.A. 2810 7533 2332 4455 N.A. N.A. N.A. 2356 7033 N.A. 2593 2211 2332 4455 N.A. N.A. N.A. 2170 5603 2810 7533 N.A. 2213 3371 2393 9511 2821 5480 2919 1300 3 Department of Health The Government of HKSAR SN090183 SN090184 SN090185 SN090186 SN090187 SN090188 SN090189 SN090190 SN090191 SN090192 SN090193 SN090194 SN090195 SN090196 SN090197 SN090198 SN090199 SN0101100 SN0101101 SN0101102 SN0101103 SN0101104 SN0101105 SN0101106 SN0101107 SN0101108 SN0101109 SN0101110 SN0101111 SN0101112 SN0101113 SN0101114 SN0101115 SN0101116 SN0101117 SN0101118 SN0101119 SN0101120 SN0101121 SN0101122 SN0101123 SN0101124 SN0101125 Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or 4.D.0.4 Software Kivi Uniloc wheelchair docking system AKE 04 Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22 (Model no H48) GE Centricity Enterprise Web 3.0 software Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630G-108) and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: Siemens Ariste MV Digital Linear Accelerator Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry System Abbott Clinical Chemistry Bilirubin Calibrator Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2 (Part no 626553) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block Accuray RoboCouch Patient Support System (Model No 025007) VIBE Quantum Pulse machine Sterilmed various products Nutricia Enteral feeding pump Schulke & Mayr Mikrozid sensitive wipes Cardinal Health Alaris GP LVP (Model 80063UN01), Alaris GP Guardrails Volumetric Pump (Model 80263UN01-G) Proact Medical Green System Duo Laryngoscope Handle GE OEC 7600 and OEC 7700 Elekta Leksell GainmaPlan / Leksell SurgiPlan Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade Roche Hitachi 917 Modular Analytics ThermoFisher Lactose peptone water with Durham s tube BO0435B Joint Replacement Instrumentation BiPolar Head A2U Nano supportive seating system Advanced Healthcare Technology Babypod II, Evo2 and Evo3 Siemens Somatom Definition AS Siemens syngo Workflow MLR Stryker Pneumo Sure XL High Flow Insufflator Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M. tuberculosis Complex, ACCUPROBE M. avium Complex Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector ThermoFisher Oxoid Staphytect Plus Dry Spot Kit Invacare Action® 2000 Manual Wheelchair Philips PCR Eleva Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no. AG55) Bausch & Lomb High Speed Vitrectomy cutter product (CX4804) Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model no 0350600006) Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000415 and 0682-000-416) Stryker Dri-Lok Disposable Cannula Philips Vertical drive brake on patient supports Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software) Accuray CyberKnife Robotic Radiosurgery System GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ Medical Device Control Office MHRA 2009/001/013/291/003 FSCA 2009/01/22 Baxter Healthcare Ltd MHRA 2009/001/012/301/001 FSCA 2009/01/22 N.A. 2807 8516 N.A. FDA N.A. Class II 2009/01/22 Varian Medical Systems Pacific Inc. 2724 2836 FDA Z-0870-2009 Class II 2009/01/22 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-0869-2009 Class II 2009/01/22 Stryker China Ltd 2518 6915 FDA Z-0857-2009 Class II 2009/01/22 Siemens Healthcare Diagnostic Limited 2810 7533 FDA Z-0581-2009 Class II 2009/01/22 Siemens Healthcare Diagnostic Limited 2810 7533 FDA FDA Z-0580-2009 Z-0532-2009 to Z-0539-2009 Class II Class II 2009/01/22 2009/01/22 Abbott Laboratories LTD. Johnson & Johnson Medical (HK) 2593 2211 2738 6027 FDA Z-0129-2009 Class II 2009/01/22 Beckman Coulter Hong Kong Ltd 2240 6150 FDA FDA FDA FDA MHRA MHRA Z-0873-2009 to Z-0882-2009 Z-0856-2009 Z-0582-2009 Z-0546-2009 to Z-0577-2009 MDA/2009/004 2008/011/019/061/022 Class II Class II Class II Class II MDA FSCA 2009/01/22 2009/01/22 2009/01/22 2009/01/22 2009/01/23 2009/01/23 N.A. Accuray Asia Ltd N.A. N.A. N.A. N.A. N.A. 2247 8628 N.A. N.A. N.A. N.A. MHRA 2009/001/005/061/007 FSCA 2009/01/23 N.A. N.A. MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA MHRA 2008/010/024/401/007 2009/001/009/061/002 2008/012/017/061/006 2009/001/007/061/008 2008/011/026/291/009 2009/001/012/601/001 2009/001/008/061/005 2008/012/023/401/006 2008/012/012/401/010 2008/012/012/291/003 2008/012/022/051/003 2009/001/016/291/004 FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA FSCA 2009/01/23 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 2009/01/29 N.A. GE Medical Systems Hong Kong Ltd. N.A. Stryker China Ltd Roche Diagnostics (Hong Kong) Ltd N.A. N.A. N.A. N.A. Siemens Healthcare Diagnostic Limited Siemens Healthcare Diagnostic Limited Stryker China Ltd N.A. 2783 1838 N.A. 2518 6915 2485 7510 N.A. N.A. N.A. N.A. 2810 7533 2810 7533 2518 6915 MHRA 2009/001/014/601/004 FSCA 2009/01/29 N.A. N.A. MHRA MHRA MHRA MHRA 2009/001/012/291/017 2008/010/017/061/003 2008/010/020/401/012 2009/001/021/291/004 FSCA FSCA FSCA FSCA 2009/01/29 2009/01/29 2009/01/29 2009/01/29 N.A. N.A. N.A. Philips Health Care (Great China) N.A. N.A. N.A. 2821 5480 Coloplast (HK) Ltd N.A. Firm Initiated Field Action 2009/01/30 Coloplast (HK) LTD 3628 7428 Bausch & Lomb N.A. Firm Initiated Field Action 2009/01/30 Bausch & Lomb (Hong Kong ) Ltd 2213 3371 FDA Z-0652-2009 Class II 2009/01/30 Stryker China Ltd 2518 6915 FDA Z-0625-2009 Class II 2009/01/30 Stryker China Ltd 2518 6915 FDA FDA Z-0868-2009 Z-0597-2009 Class II Class II 2009/01/30 2009/01/30 Stryker China Ltd Philips Health Care (Great China) 2518 6915 2821 5480 FDA Z-0001-2009 Class II 2009/01/30 Philips Health Care (Great China) 2821 5480 FDA FDA Z-0629-2009 Z-0473-2009 to Z-0475-2009 Class II Class II 2009/01/30 2009/01/30 Accuray Asia Ltd GE Medical Systems Hong Kong Ltd. 2247 8628 2783 1838 4 Department of Health The Government of HKSAR SN0101126 SN0101127 SN0101128 SN0101129 SN0101130 SN0101131 SN0101132 SN0101133 SN0101134 SN0101135 SN0101136 SN0101137 SN0101138 SN0101139 SN0101140 SN0101141 SN0101142 Cardinal Health Esmark Elastic Bandage INGfertility Pre Isotonic Personal Lubricant labeled PRE Patient Lubricant Alimed Gait Belt (Transfer Aid) (Model 72108, 72109) Quantimetrix QuanTscopics Urine Microscopics Contro Hill- Rom 70 Semi-Electric Bed (Model HS-968) Ansell Healthcare Products Conform XT - Gloves (Model: 69318) Ossur HF ReSolve Open Back Halo Ring Maquet Reservoirs (BEQ-VHK 2001) Styker Dri-Lok Disposable Cannulas BHM Medical Ergolift, Ergolift-2 Roche Diagnostics Process System Manager (Model: 3009696001) Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K) Harvest Technologies Autologous Platelet Concentrate System (Model: APC-201) Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost Eleva - Flat Detector (70834), C) Omnidiagnost Eleva White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia Disc MC Healthcare Products QP2508 Hand Pendant (Model: HB43U010-00/01 Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500415) Medical Device Control Office FDA FDA FDA FDA FDA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada Z-0615-2009 to Z-0616-2009 Z-0626-2009 Z-0598-2009 Z-0513-2009 to Z-0516-2009 Z-0506-2009 45563 45100 45565 45616 45626 45358 41402 Class II Class II Class II Class II Class II Type II Type II Type II Type II Type I Type I Type II 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 2009/01/30 N.A. N.A. N.A. N.A. N.A. N.A. N.A. Maquet Hong Kong LTD. Stryker China Ltd Arjo Huntleigh (Hong Kong) Ltd. Roche Diagnostics (Hong Kong) Ltd Baxter Healthcare Ltd N.A. N.A. N.A. N.A. N.A. N.A. N.A. 2393 9511 2518 6915 2508 1416 2485 7510 2807 8516 Health Canada 45706 Type II 2009/01/30 N.A. N.A. Health Canada 45311 Type II 2009/01/30 Philips Health Care (Great China) 2821 5480 Health Canada 44705 Type II 2009/01/30 N.A. N.A. Health Canada 45786 Type II 2009/01/30 N.A. N.A. Health Canada 45802 Type II 2009/01/30 N.A. N.A. 5 Department of Health The Government of HKSAR Device Safety Alerts - December 2008 s and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SN081201 Autoadapt DriveLOC and Carosafe II MHRA 2008/003/006/301/002 FSCA 01-Dec-08 N/A N/A SN081202 Liko LikoScale 200 MHRA 2008/005/029/401/009 FSCA 01-Dec-08 N/A N/A SN081203 Diamed ID DiaScreen Prophylax MHRA 2008/011/021/061/012 FSCA 01-Dec-08 DIAMED-CHINA LTD. 251 262 38 SN081204 ThermoFisher Staphaurex Plus MHRA 2008/011/024/601/002 FSCA 01-Dec-08 N/A N/A SN081205 Philips Omni, Multi and Easy Diagnost Systems using GCF Velara Generator with Tube Grid switch MHRA 2008/011/021/291/003 FSCA 01-Dec-08 Philips Healthcare - Great China 2821 5480 SN081206 Zimmer Silhouette Axial Torque Wrench MHRA 2008/011/021/061/010 FSCA 01-Dec-08 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN081207 Edwards Lifesciences Aquarius software operating manuals MHRA 2008/011/024/291/007 FSCA 01-Dec-08 N/A N/A SN081208 Siemens Syngo Dynamics version 4.2, 5.x, 6.0 MHRA 2008/009/008/061/001 FSCA 02-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081209 Integra LifeSciences Uni-CP Compression Forceps (Spreader) (Catalog no 339001ND) FDA Z-0307-2009 Class II 04-Dec-08 N/A N/A SN081210 Boston Scientific RF Ablation System Foot Switch Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 05-Dec-08 Boston Scientific Hong Kong Ltd 2960 7136 SN081211 Boston Scientific Flextome Cutting Balloon w/Over-the-Wire Delivery System Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 05-Dec-08 Boston Scientific Hong Kong Ltd 2960 7136 SN081212 Johnson and Johnson ENDOPATH Electrosurgery Probe Plus II Johnson & Johnson Medical (HK) N/A Firm Initiated Field Action 05-Dec-08 Johnson & Johnson Medical (HK) 2738 6027 SN081213 Medtronic EnTrust® Implantable Cardioverter Defibrillators MHRA 2008/011/021/061/005 FSCA 08-Dec-08 Medtronic International, Ltd. 2907 5911 SN081214 Otto Bock Healthcare 3R66 – Modular Polycentric Knee Joint MHRA 2008/011/006/301/001 FSCA 08-Dec-08 N/A N/A SN081215 Varian Linear accelerators other than Clinac Varian Medical Systems Pacific Inc. N/A Firm Initiated Field Action 10-Dec-08 Varian Medical Systems Pacific Inc. 2722 8123 SN081216 GE Healthcare CT/e and HiSpeed X/I families of Computed Tomography systems GE Medical Systems Hong Kong Ltd. N/A Firm Initiated Field Action 10-Dec-08 GE Medical Systems Hong Kong Ltd. 2783 1888 SN081217 Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric Infusion Pumps 2M8153K and 2M9163 MHRA 2008/011/028/061/015 FSCA 15-Dec-08 Baxter Healthcare Ltd 2807 8555 SN081218 AMO Healon D Ophthalmic Viscosurgical Device (Lot No. UD30654) FDA Z-0343-2009 Class I 15-Dec-08 AMO Asia Limited 2480 3330 SN081219 Integra NeuroSciences Gravity Compensating Accessory FDA Z-0458-2009 Class I 15-Dec-08 N/A N/A SN081220 Posey Synthetic Leather and Biothane Waist and Wrist Restraints (Catalog No 2217SL and 2217B) FDA Z-0286-2009 Class II 15-Dec-08 N/A N/A SN081221 Siemens AXIOM Artis System FDA Z-0312-2009 to Z-0317-2009 Class II 15-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081222 Siemens syngo MultiModality WorkPlace (MM WP), software product (Model No 10140720) FDA Z-0324-2009 Class II 15-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081223 Terumo Sarns Sternal Saw II System Power Unit FDA Z-0358-2009 to Z-0359-2009 Class II 15-Dec-08 TERUMO CHINA (H.K.) LTD. 2529 0451 Medical Device Control Office 6 Department of Health The Government of HKSAR SN081224 SN081225 Medtronic 5F, 6F, 7F BardSelect 1cm Percutaneous Catheter Introducer Set Johnson and Johnson STERRAD NX Sterilizer (Product Code 10033) FDA Z-0441-2009 to Z-0444-2009 Class II 15-Dec-08 Medtronic International, Ltd. 2907 5911 FDA Z-0484-2009 Class II 15-Dec-08 Johnson & Johnson Medical (HK) 2738 6027 SN081226 Radiometer Calibrator 1 Solution for the ABL700 Series FDA Z-0457-2009 Class II 15-Dec-08 N/A N/A SN081227 Cardinal Health GSI Audera (version 2.6 Software) System FDA Z-0195-2009 Class II 15-Dec-08 N/A N/A SN081228 Stryker Pain Pump 2 Blockaid (0575-100-000) Health Canada 44921 Type II 17-Dec-08 Stryker China Ltd 2518 6988 SN081229 Smiths Medical Disposable Norothermic IV Admin. Sets (DI-100, DI50) Health Canada 44870 Type II 17-Dec-08 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SN081230 Oxoid Filteredhorse Serum (SR0035C) Health Canada 44449 Type II 17-Dec-08 South East Chemical & Instrument Ltd 28026333 SN081231 BHM Battery Model NDA 0200-20 Health Canada 45060 Type II 17-Dec-08 BHM Medical Inc. N/A SN081232 Technidata TD-Synergy Software (TD-SYS-01) Health Canada 44744 Type II 17-Dec-08 N/A N/A SN081233 Orasure Intercept Mirco-Plate EIA Kit (Model: 61452, 61454, 61456) Health Canada 44505 Type II 17-Dec-08 N/A N/A SN081234 Hill-Rom Liko Uno 100, 101, 102 Patient Lift Health Canada 44701 Type II 17-Dec-08 N/A N/A Health Canada 44646 Type II 17-Dec-08 N/A N/A Health Canada 44525 Type II 17-Dec-08 Philips Healthcare - Great China 2821 5480 SN081235 SN081236 InteleViewer module of the Intel PACS and Intele Viewer Workstation (V3-X-X) Philips EGM Essential Gas Module (GI M1013A, G5 M1019A), Intellivue Patient Monitoring Sys. (M8002A, M8004A, M8007A), Intellivue Patient Monitor (M8105A M8105AT) Clinical Instruments Carotid Shunt Outlying / Inlying with T-Port Health Canada 44867 Type II 17-Dec-08 N/A N/A SN081238 Beckman Coulter UniCel Dxl Access Immunoassay Systems Wash Buffer II Lots 70662 and 70637 MHRA 2008/011/027/601/001 FSCA 17-Dec-08 Beckman Coulter Hong Kong Ltd 2240 6150 SN081239 Siemens CT Syngo Dual Energy Viewer MHRA 2008/010/031/061/006 FSCA 17-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081240 Fresenius Medical Care 5008 dialysis machine MHRA 2008/012/001/061/001 FSCA 17-Dec-08 N/A N/A SN081241 Smiths Medical Deltec Cozmo Insulin Pump Model number 1800 MHRA 2008/011/027/061/013 FSCA 17-Dec-08 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SN081242 Terumo Sarns Level Sensor II Pads (Ref 195240) FDA Z-0311-2009 Class II 18-Dec-08 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081243 Terumo Advanced Perfusion System 1 (Model no.: 801040, 801041, 816570, 816571) FDA Z-0354-2009 to Z-0357-2009 Class II 18-Dec-08 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081244 GE Centricity PACS RA1000 Workstation FDA Z-0460-2009 Class II 18-Dec-08 GE Medical Systems Hong Kong Ltd. 2783 1888 SN081245 Siemens Dade Behring Dimension Enzymatic Creatinine Flex reagent cartridge, DF270 FDA Z-0485-2009 Class II 18-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081246 Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit FDA Z-0414-2009 Class II 18-Dec-08 N/A N/A SN081247 Acumed Modular Shoulder Body Assembly FDA Z-0477-2009 Class II 18-Dec-08 N/A N/A SN081248 Promega RNAgents Total RNA Isolation System (Cat. #Z5110) FDA Z-0483-2009 Class II 18-Dec-08 Bio-Gene Technology Ltd 2646 6101 SN081249 Medtronic LIFEPAK®9, LIFEPAK 9P, LIFEPAK 12, LIFEPAK 20/20e External Sterilizable Paddles and Pediatric Paddles MHRA 2008/011/024/291/001 FSCA 19-Dec-08 Medtronic International, Ltd. 2907 5911 SN081250 Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades FDA N/A Class I 22-Dec-08 N/A N/A SN081237 Medical Device Control Office 7 Department of Health The Government of HKSAR SN081251 Bard feeding kits (containing ConMed grasping snares) SN081252 Medtronic Reveal DX Insertable Cardiac Monitor (ICM) SN081253 Joerns Healthcare Oxford disposable slings SN081254 Stryker Custom Cranial Implant Kits SN081255 SN081256 Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale, Manual 4-Point DPS and scale Bard Pacific Health Care Co Ltd Medtronic International Ltd N/A Firm Initiated Field Action 22-Dec-08 Bard Pacific Health Care Co Ltd 886-2-2503-1900 N/A Firm Initiated Field Action 23-Dec-08 Medtronic International, Ltd. 2907 5911 MHRA MDA/2008/088 MDA 23-Dec-08 N/A N/A FDA N/A Class I 29-Dec-08 Stryker China Ltd 2518 6988 FDA Z-0338-2009 Class II 30-Dec-08 Boston Scientific Hong Kong Ltd 2960 7136 FDA Z-0412-2009 to Z-0413-2009 Class II 30-Dec-08 Arjo Huntleigh (Hong Kong) Ltd 2508 9553 SN081257 Beckman Coulter Vidiera NsP Nucleic Sample Preparation FDA Z-0454-2009 Class II 30-Dec-08 Beckman Coulter Hong Kong Ltd 2240 6150 SN081258 Alfa Wassermann ACE and ACE Alera Hemoglobin A1C FDA Z-0482-2009 Class II 30-Dec-08 N/A N/A SN081259 FHC MicroTargeting Electrode FDA Z-0497-2009 to Z-0498-2009 Class II 30-Dec-08 N/A N/A SN081260 Arjo Maxi Move, Model NDA0200-20 Batteries Pack FDA Z-0503-2009 Class II 30-Dec-08 Arjo Huntleigh (Hong Kong) Ltd 2508 9553 SN081261 Bk Medical Single-use sterile puncture attachment UA1256-U FDA Z-0504-2009 Class II 30-Dec-08 N/A N/A SN081262 Boston Scientific Convoy Advanced Delivery Sheath Kits Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 30-Dec-08 Boston Scientific Hong Kong Ltd 2960 7136 SN081263 Boston Scientific Gold Probe Single-Use Bi-Polar Electrohemostasis Catheters Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 30-Dec-08 Boston Scientific Hong Kong Ltd 2960 7136 SN081264 Wescott Medical Sae-Flo MD Extension Set with Y-Connector MHRA 2008/010/022/601/001 FSCA 31-Dec-08 N/A N/A SN081265 Siemens Leonardo Workstation MHRA 2008/004/010/061/006 FSCA 31-Dec-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081266 Biotronik EDP 30/A MHRA 2007/002/007/401/009 FSCA 31-Dec-08 N/A N/A Medical Device Control Office 8 Department of Health The Government of HKSAR Device Safety Alerts - November 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No FDA N/A Class I 2009/11/03 N/A N/A SN081101 vibe Technologies, Vibrational Integrated Biophotonic Energizer (VIBE) Machine Multi-Frequency Field Generator SN081102 Beckman Coulter UniCel® DxI® 800 and UniCel DxI 600 Access® Immunoassay Systems and UniCel DxC 880i SYNCHRON® Access Clinical System MHRA 2008/010/027/601/002 FSCA 2008/11/03 Beckman Coulter Hong Kong Ltd N/A SN081103 Smiths Medical Wallace Oocyte Recovery Needle MHRA 2008/010/022/061/011 FSCA 2008/11/03 N/A N/A SN081104 Pride Jazzy 1121 power chairs MHRA 2008/004/024/401/003 FSCA 2008/11/03 N/A N/A SN081105 TomoTherapy Hi-Art System MHRA 2008/010/014/061/018 FSCA 2008/11/03 N/A N/A SN081106 Teleflex Medical Great Ormond Street Tracheostomy Cannula Set MHRA 2008/006/018/061/013 FSCA 2008/11/03 N/A N/A SN081107 Cardiac Science Powerheart AEDs MHRA 2008/002/011/061/010 FSCA 2008/11/03 N/A N/A SN081108 TerumoTenderflow Pediatric Arterial Cannula MHRA 2008/010/028/061/006 FSCA 2008/11/03 N/A N/A SN081109 Biomet Various AGC /5+ Reamer /Hiploc Instrument cases MHRA 2008/010/027/601/003 FSCA 2008/11/03 N/A N/A SN081110 Biomet EZloc Femoral Fixation 9-10mm Standard Length -- 904781 MHRA 2008/010/014/601/004 FSCA 2008/11/03 N/A N/A SN081111 Abbott Voyager NC Coronary Dilatation Catheter (4.5mm diameter) Abbott Laboratories Ltd N/A Firm Initiated Field Action 2008/11/05 Abbott Laboratories Ltd. 2593 2211 SN081112 Tyco Healthcare (Covidien) ReliOn Insulin Syringes FDA N/A Press Release 2008/11/06 Tyco Healthcare (HKSAR) LTD 3157 7220 SN081113 Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation FDA Z-0184-2009 to Z-0187-2009 Class II 2008/11/07 Medtronic International, Ltd. 2907 5911 SN081114 B Braun Smallbore T-Port Extension Set (Item no 474515) ( FDA Z-0199-2009 Class II 2008/11/07 B Braun Medical Hong Kong 2277 6125 FDA Z-0163-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 FDA Z-0086-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 SN081115 SN081116 Siemens Axiom Aristos FX Multipurpose Radiography System (Model no 7414803) Siemens Acuson/Sonovista X300 Ultrasound systems (Software version 2.0.1 - 2.0.05, 3.0.01 and 3.0.02 SN081117 Siemens Coherence Therapist Systems FDA Z-0089-2009 to Z-0099-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 SN081118 Siemens Syngo Imaging with versions VB20B, VB20D, VB20G, VB25B,VB30A, VB30A-SP1 and VB30A-SP2 (Model no 10014063) FDA Z-0102-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 SN081119 Siemens Acuson X300 Ultrasound Systems (Model no. 10037409, 10038837, 10348531, 10132987, 10133170, 10348532, 10348533) FDA Z-0111-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 SN081120 Siemens Artiste MV System (Part no 8139789) FDA Z-0116-2009 Class II 2008/11/07 Siemens Healthcare Diagnostic Limited 2810 7533 SN081121 Stryker Osteosynthesis Reduction Spoon (Product Code 1806-0125) FDA Z-0191-2009 Class II 2008/11/07 Stryker China Ltd 2518 6988 SN081122 Stryker Ray TFC Device with End Caps FDA Z-0151-2009 Class II 2008/11/07 Stryker China Ltd 2518 6988 Medical Device Control Office 9 Department of Health The Government of HKSAR SN081123 GE Centricity Perinatal (formerly Quantitative Sentinel) System Fluid Total Precision Software FDA Z-0112-2009 Class II 2008/11/10 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081124 Baxter Auto Syringe AS50 Infusion Pump (Product Code 1M8550) FDA Z-0152-2009 Class II 2008/11/10 Baxter Healthcare Ltd 2807 8500 SN081125 Roche Diagnostic LDL_C, IRON2, CREP2, STFR, HDLC3, ALBT2, NAPA2 FDA Z-0006-2009 to Z-0012-2009 Class II 2008/11/10 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN081126 Roche/Hitachi Modular E Module immunoassay analyzer (GMMI Nos. 04998642001 and 03617505001) FDA Z-0165-2009 Class II 2008/11/10 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN081127 Philips Respiratory Gating System (Model # 455011203131 and 455011203191) FDA Z-0132-2009 Class II 2008/11/10 Philips Healthcare - Great China 2821 5480 SN081128 Philips M3811B Telemonitoring Clinical Review Software (version Build 1.1.2.11d, B.02.07) FDA Z-0100-2009 Class II 2008/11/10 Philips Healthcare - Great China 2821 5480 SN081129 Smith & Nephew GlobTek, Inc. Power Supply for Medical Use (Par no: TR9CE4000LCP-Y-MED Model GTM21097-5012) FDA Z-0162-2009 Class II 2008/11/10 Smith & Nephew Limited 2648 7700 SN081130 Facet Technologies Premier Value Lancing Device (UPC Code: 840986016707) FDA Z-0174-2009 Class II 2008/11/10 N/A N/A SN081131 Biomet brand Modular Microplasty Cup Inserter (Model 31-400600) FDA Z-0181-2009 Class II 2008/11/10 N/A N/A SN081132 Pointe Scientific Liquid AST (SGOT) Reagent Set, AST R1 Reagent FDA Z-0171-2009 Class II 2008/11/10 N/A N/A SN081133 Maquet Accessory Head Rest for Alphastar Operating Tables (USA Part no 1130 67FO) FDA Z-0161-2009 Class II 2008/11/10 Maquet Hong Kong Ltd 2393 9511 SN081134 Allez Spine Laguna Pedicle Screw System, Del Mar Pedicle Screw System, Cross Connectors FDA Z-0153-2009 to Z-0155-2009 Class II 2008/11/10 N/A N/A SN081135 Intraop Medical Mobetron Model 1000, mobile electron linear accelerator FDA Z-0014-2009 Class II 2008/11/10 N/A N/A SN081136 Medline Latex Free C- Section CDS-LF, Vaginal Delivery CDS-LF, Labor Kit & Postpartum CDS-LF, Mom/Baby Admit Kit-LF FDA Z-0015-2009 to Z-0019-2009 Class II 2008/11/10 N/A N/A SN081137 Hill-Rom Envision E700 Low Airloss Therapy Surface FDA Z-0088-2009 Class II 2008/11/10 N/A N/A SN081138 Applied Medical Separator Abdominal Access System, Lap Banding Kit, Lap Roux-EN-Y Kit FDA Z-0023-2009 to Z-0029-2009 Class II 2008/11/10 N/A N/A SN081139 Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System FDA Z-0035-2009 to Z-0085-2009 Class II 2008/11/10 N/A N/A SN081140 Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6 FDA Z-0113-2009 Class II 2008/11/10 Cook Asia (Hong Kong) Ltd. 2781 0232 SN081141 Joerns Healthcare Mermaid, Dipper and Ranger bath hoists MHRA MDA/2008/079 MDA 2008/11/10 N/A N/A SN081142 Tosoh Bioscience TSKgel G8 Variant HSi MHRA 2008/011/003/061/010 FSCA 2008/11/10 N/A N/A SN081143 Roche Diagnostics MODULAR ANALYTICS Software version 08.03 MHRA 2008/010/030/061/016 FSCA 2008/11/10 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN081144 Siemens Syngo Imaging MHRA 2008/010/031/061/003 FSCA 2008/11/10 Siemens Healthcare Diagnostic Limited 2810 7533 SN081145 CODAN Pressure Monitoring Kit STP-90R MHRA 2008/002/028/401/002 FSCA 2008/11/10 N/A N/A SN081146 Stryker Humerus Head Fixed and HMRS - Distal Humerus Cone MHRA 2008/010/015/061/005 FSCA 2008/11/11 Stryker China Ltd 2518 6988 Medical Device Control Office 10 Department of Health The Government of HKSAR SN081147 Biomet AGC V2 Total Knee Moulded ArComTibial Components MHRA 2008/009/025/401/008 FSCA 2008/11/11 N/A N/A SN081148 ThermoFisher BO0077M, Tryptone soya broth MHRA 2008/011/005/601/005 FSCA 2008/11/11 N/A N/A SN081149 GE Healthcare Signa MR 2239500, 5116064 and 5118162 MHRA 2008/011/004/051/004 FSCA 2008/11/11 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081150 Bio-Rad Variant II Turbo Hemoglobin Testing System with CDM 4.0 MHRA 2008/011/005/061/009 FSCA 2008/11/11 N/A N/A SN081151 Bio-Rad Variant II Turbo HCook Zenith Flex AAA Endovascular Graft emoglobin Testing System with CDM 4.0 MHRA 2008/008/007/061/009 FSCA 2008/11/12 Cook Asia (Hong Kong) Ltd. 2781 0232 SN081152 Maquet Pedal 1009.81 for operating tables MHRA 2008/011/003/061/013 FSCA 2008/11/12 Maquet Hong Kong Ltd N/A SN081153 KYMCO Healthcare Midi XL MHRA 2008/010/027/261/001 FSCA 2008/11/12 N/A N/A SN081154 Days healthcare Strider Maxi and Strider Midi 4+ MHRA 2008/010/023/301/002 FSCA 2008/11/12 N/A N/A SN081155 Sunrise Medical OXFORD Midi 150A lifts MHRA 2008/004/014/401/003 FSCA 2008/11/13 N/A N/A SN081156 Marshall Products adult and paediatric manual resuscitators MHRA 2008/010/029/401/001 FSCA 2008/11/13 N/A N/A SN081157 TSCI Fluido SA 200 MHRA 2008/011/006/051/008 FSCA 2008/11/13 N/A N/A SN081158 Biomet Vanguard Width Checker 67.5 / 70 / 75 Health Canada 40888 Type II 2008/11/14 Goodman Medical Supplies Ltd 2332 4455 SN081159 Siemens AG Syngo Imaging (Model 10014063) Health Canada 44245 Type II 2008/11/14 Siemens Healthcare Diagnostic Limited 2810 7533 SN081160 B-K Medical Single Use Sterile Puncture UA 1256-U Health Canada 44063 Type II 2008/11/14 S & V Sanford Instrument N/A SN081161 Roche Hitachi D-Dimer Health Canada 43711 Type II 2008/11/14 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN081162 Kerr Premise Unidose Health Canada 44081 Type II 2008/11/14 N/A N/A SN081163 Ondal Stryker Vision 3 Elect Mon Shroud Health Canada 44076 Type II 2008/11/14 Stryker China Ltd 2518 6988 SN081164 Ondal Flat Panel/Navigation Arm Health Canada 44179 Type II 2008/11/14 Stryker China Ltd 2518 6988 SN081165 Biomet Microfixation Lactosorb 1.5MM 8Hole STR EXT Plate Health Canada 43369 Type II 2008/11/14 Goodman Medical Supplies Ltd 2332 4455 SN081166 GE Centricity PACS Software Health Canada 42408 Type II 2008/11/14 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081167 Medtronic Synchromed EL, Synchromed II infusion pumps Health Canada 44005 Type II 2008/11/14 Medtronic International, Ltd. 2907 5911 SN081168 Terumo Advanced Perfusion System 1 Health Canada 42752 Type II 2008/11/14 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081169 Synthes sternal Fixation System - Cable Ferrule Health Canada 44393 Type II 2008/11/14 N/A N/A SN081170 Siemens Somatom Sensation / Cardiac 64 Health Canada 44298 Type II 2008/11/14 Siemens Healthcare Diagnostic Limited 2810 7533 SN081171 Tripath Prepstain System Health Canada 44291 Type II 2008/11/14 BD Asia Ltd (Hong Kong) 2575 8668 SN081172 Medrad 3.0 T Prostat eCoil Health Canada 44234 Type II 2008/11/14 Ultronics Enterprises Ltd 2764 5208 SN081173 Terumo Level Sensor Transducer Health Canada 43401 Type II 2008/11/14 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081174 TomoTherapy Hi-Art System Health Canada 44265 Type II 2008/11/14 N/A N/A Medical Device Control Office 11 Department of Health The Government of HKSAR SN081175 Gambro Prismaflex system Health Canada 44403 Type II 2008/11/14 Gambro China Ltd N/A SN081176 Gerno Model 35X Proflexx Stretcher Health Canada 44082 Type II 2008/11/14 Goodman Medical Supplies Ltd 2332 4455 SN081177 BC Unicel DXC 6001 Assay Protocol File, Access Immunoassay system Protocol file, Access System 2 Protocol File, Sysnchron LXI 725 Assay Protocol file Health Canada 44259 Type II 2008/11/14 Beckman Coulter Hong Kong Ltd 2240 6150 SN081178 Pascal Siltrax Plus 8 Gingival Retraction Cord Health Canada 43384 Type II 2008/11/17 N/A N/A SN081179 ACS Holter Reporter Master VII Analyzer Health Canada 43854 Type II 2008/11/17 N/A N/A SN081180 Angio 3-0 Nylon Suture Product Health Canada 44163 Type I 2008/11/17 N/A N/A SN081181 Thomas Medical Products 18 gage XTW needles FDA Z-0131-2009 Class II 2008/11/17 N/A N/A SN081182 7F Bard SSV 13 cm Split Sheath with Valve and sideport (Catalog No: 808700) FDA Z-0280-2009 Class II 2008/11/17 N/A N/A SN081183 Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3 FDA Z-0207-2009 Class II 2008/11/17 N/A N/A SN081184 Drummond Scientific Iris Sample Processing SafeCrit 75mm and 40mm Tubes, Separation Technology ClearCRIT Capillary Tubes FDA Z-0208-2009 to Z-0211-2009 Class II 2008/11/17 N/A N/A SN081185 Iverness Medical BioStar OIA FLU AB (Catalog 90007) FDA Z-0212-2009 Class II 2008/11/17 N/A N/A SN081186 Pointe Scientific Liquid Glucose HEX (R1); HEX (R2); HEX; HEXO Reagent Sets FDA Z-0219-2009 to Z-0224-2009 Class II 2008/11/17 N/A N/A SN081187 Porter Instrument Bag Tee Assembly Model (P1407A) FDA Z-0228-2009 Class II 2008/11/17 N/A N/A SN081188 Biomet Microfixation HT X-Drive Screw FDA Z-0282-2009 Class II 2008/11/17 N/A N/A SN081189 Advanced Bionics Preision Charger 1.0 (Model # SC-5300) FDA Z-0271-2009 Class II 2008/11/17 N/A N/A SN081190 Alcon PurePoint System Operator's Manual (Catalog no 8065751131 Rev. B) FDA Z-0274-2009 Class II 2008/11/17 Alcon Hong Kong Ltd 2568 0636 SN081191 Terumo Sarns Level Sensor II (Yellow and Red) (Part # 195215 and # 195274) FDA Z-0295-2009 to Z-0296-2009 Class II 2008/11/17 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081192 TERUMO Advanced Perfusion System 1 Base (Model 801763 and 801764) FDA Z-0203-2009 to Z-0204-2009 Class II 2008/11/17 TERUMO CHINA (H.K.) LTD. 2866 0811 SN081193 Siemens AXIOM Artis and Artis zee FDA Z-0193-2009 to Z-0194-2009 Class II 2008/11/17 Siemens Healthcare Diagnostic Limited 2810 7533 SN081194 Animas (Johnson & Johnson ) One Touch Ping Glucose Monitoring System FDA Z-0283-2009 Class II 2008/11/17 Johnson & Johnson Medical (HK) 2738 6027 SN081195 Stryker Hipstar V40 Femoral Stem Howemedica FDA Z-0227-2009 Class II 2008/11/17 Stryker China Ltd 2518 6988 SN081196 Gyrus ACMI (Olympus) dissector PlasmaKnife (DPK) (Catalog no 7035-3005) FDA Z-0273-2009 Class II 2008/11/17 Olympus Hong Kong and China Limited 2170 5678 SN081197 Philips Intera, Achieva and Panorama HFO (Philips MR), 3160 (Precess) MRI Patient Monitoring System (Invivo) MHRA 2008/009/025/061/013 FSCA 2008/11/17 Philips Healthcare - Great China 2821 5480 SN081198 Unomedical Unilect 4831Q and 4841P Short Term Monitoring Electrodes MHRA 2008/010/023/061/011 FSCA 2008/11/18 N/A N/A SN081199 Siemens ADVIA Centaur® and ACS:180® Systems MHRA 2008/011/004/061/009 FSCA 2008/11/18 N/A N/A Medical Device Control Office 12 Department of Health The Government of HKSAR SN0811100 B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and 7107365 SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm MHRA 2008/010/007/061/011 FSCA 2008/11/18 B Braun Medical Hong Kong 2277 6125 MHRA 2008/010/030/061/008 FSCA 2008/11/18 Stryker China Ltd 2518 6988 Johnson & Johnson Medical (HK) N/A Firm Initiated Field Action 2008/11/19 Johnson & Johnson Medical (HK) 2738 6027 Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/11/19 Baxter Healthcare Ltd 2807 8516 SN0811104 Beckman Coulter Power Processor with LX Connections, 6605741 MHRA 2008/011/005/601/001 FSCA 2008/11/20 Beckman Coulter Hong Kong Ltd 2240 6150 SN0811105 Clinical Innovations ClearView Uterine Manipulator MHRA 2008/011/013/061/003 FSCA 2008/11/20 N/A N/A SN0811106 Coloplast EasiCath Catheter and EasiCath Luer Lock Catheter MHRA 2008/011/011/291/008 FSCA 2008/11/20 N/A N/A SN0811107 Stanmore Implants METS Femoral Shaft MHRA 2008/011/014/061/012 FSCA 2008/11/20 N/A N/A FDA Z-0287-2009 Class II 2008/11/21 Boston Scientific Hong Kong Ltd 2960 7136 SN0811102 Johnson & Johnson Sterrad 100S Sterilizers SN0811103 Baxter COLLEAGUE Triple Channel Mono CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153K) Boston Scientific NAMIC Custom Angiographic Kit SN0811108 (REF/Catalog#60190254) SN0811109 Sunquest Laboratory System (Software version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3) FDA Z-0214-2009 Class II 2008/11/21 N/A N/A SN0811110 Gabauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) (P/N 0386-0020-20) FDA Z-0218-2009 Class II 2008/11/21 N/A N/A SN0811111 Smith & Nephew SOFTSILK 1.5 SCREW, 8mm x 20mm MHRA 2008/011/014/061/008 FSCA 2008/11/21 N/A N/A SN0811112 Codman, A J&J Archimedes implantable infusion pump MHRA 2008/004/021/061/008 FSCA 2008/11/21 Johnson & Johnson Medical (HK) 2738 6027 Comis Orthopaedics MIHR Modular Femoral Head Sleeve Size 0, product code 028-10-2 MHRA 2008/009/002/061/011 FSCA 2008/11/21 N/A N/A Philips IntelliVue Patient Monitors (the table mount, part# M8000SN0811114 64100) MHRA 2008/011/019/061/021 FSCA 2008/11/24 Philips Healthcare - Great China 2821 5480 SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines) MHRA 2008/011/018/601/002 FSCA 2008/11/24 GE Medical Systems Hong Kong Ltd. 2783 1838 SN0811113 SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096) Health Canada 44383 Type II 2008/11/24 N/A N/A SN0811117 Siemens Axiom Luminos DRF (Model 10252047) Health Canada 44442 Type II 2008/11/24 Siemens Healthcare Diagnostic Limited 2810 7533 SN0811118 Fisher and Paykel RT240 & RT340 Adult Breathing Circuit Health Canada 44527 Type II 2008/11/24 Foxwood Medical Supplies 2770 6877 SN0811119 Smiths Potex Blue Line Ultra Tracheostomy Kit (Model 100/812/070) Health Canada 44440 Type II 2008/11/24 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SN0811120 Siemens Symbia T Series (Model 10275009) Health Canada 44551 Type II 2008/11/24 Siemens Healthcare Diagnostic Limited 2810 7533 Health Canada 44535 Type II 2008/11/24 Arjo Huntleigh (Hong Kong) Ltd 2508 9553 MHRA 2008/011/003/061/012 FSCA 2008/11/26 N/A N/A FDA Z-0004-2009 Class II 2008/11/28 Johnson & Johnson Medical (HK) 2738 6027 FDA Z-2388-2008 Class II 2008/11/28 Medtronic International, Ltd. 2907 5911 SN0811125 Terumo Advanced Perfusion System 1 (Model 801040 and 801041) FDA Z-0309-2009 to Z-0310-2009 Class II 2008/11/28 TERUMO CHINA (H.K.) LTD. 2866 0811 Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H00SN0811126 01, 08H00-03) FDA Z-0306-2009 Class II 2008/11/28 Abbott Laboratories Ltd. 2593 2211 SN0811121 SN0811122 SN0811123 SN0811124 BHM Arjo Maxi 500 (KM560101, KM560104, KM560108, KM560181, KM560184, KM560188) Bard WIZARD Dual Port Low Profile Replacement Gastrostomy Device Johnson and Johnson Lifescan One Touch Litra Test Strips (Part no 020-994-02) Medtronic Physio-Control Lifepak 20 Defibrillator/monitor Medical Device Control Office 13 Department of Health The Government of HKSAR SN0811127 Biomet Vanguard DCM Plus 16mm x 63/67mm Tibial Bearing (REF 183726) FDA Z-0289-2009 Class II 2008/11/28 N/A N/A SN0811128 Zimmer Alumina Ceramic Femoral Head FDA Z-0299-2009 to Z-0304-2009 Class II 2008/11/28 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 Stelkast Proven Cemented Semi-Constrained Total Knee (Part No. SN0811129 SC1591-38) FDA Z-0308-2009 Class II 2008/11/28 N/A N/A SN0811130 Theken Spine Bone Marrow Aspiration Kit (Part no 50-20-001) FDA Z-0272-2009 Class II 2008/11/28 N/A N/A Medical Device Control Office 14 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - October 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC), Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector SN081001 Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment Revision Kit (Model 8596SC) Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No FDA Z-2380-2008 to Z-2383-2008 Class I 02-Oct-08 Medtronic International, Ltd. 2907 5911 SN081002 Medtronic IsoMed Refill Kit (Model 8553) FDA Z-1903-2008 Class II 02-Oct-08 Medtronic International, Ltd. 2907 5911 SN081003 Stryker Osteonics Scorpio Total Knee FDA Z-2079-2008 Class II 02-Oct-08 Stryker China Ltd 2518 6988 SN081004 Stryker Hoffman II compact Sterile Wrist Kit FDA Z-2080-2008 Class II 02-Oct-08 Stryker China Ltd 2518 6988 SN081005 Stryker Universal Notch Preparation Guide amd X-Celerate Universal Block Pegless FDA Z-1690-2008 to Z-1691-2008 Class II 02-Oct-08 Stryker China Ltd 2518 6988 SN081006 GE Healthcare Definium 8000 Digital Radiographic System FDA Z-1822-2008 Class II 02-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081007 GE Healthcare Definium 8000 Digital Radiographic System FDA Z-1882-2008 Class II 02-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081008 GE Definium 8000 (model 5135678) and GE Precision 500D (model 2403790-3) FDA Z-1476-2008 to Z-1477-2008 Class II 02-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081009 GE OEC 9600 C-arm Fluoroscopy System FDA Z-1709-2008 Class II 02-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081010 GE 1.5T and 3.0 T Signa HDx MR System and GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System FDA Z-2210-2008 to Z-2211-2008 Class II 02-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081011 Siemens Radiation Therapy Systems FDA Z-2095-2008 to Z-2104-2008 Class II 02-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081012 Siemens Ultrasound Transducer 17L5HD FDA Z-2230-2008 Class II 02-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081013 Accuray CyberKnife Ronotic Radiosurgery System radiation therapy device FDA Z-2056-2008 Class II 02-Oct-08 Accuray Asia Ltd 2247 8628 SN081014 Varian VariSource CT/MR Ring & Tandem Applicator Set FDA Z-2081-2008 Class II 02-Oct-08 Varian Medical Systems Pacific Inc. 2724 2836 SN081015 Smith & Nephew TRIGEN Hind Foot Fusion Nail FDA Z-2082-2008 to Z-2088-2008 Class II 02-Oct-08 Smith & Nephew Limited SN081016 Merit Medical Arnot-Ogden Med Ctr Hip Pack (REF: K12T-02160A and K12T-02159A) FDA Z-1808-2008 to Z-1809-2008 Class II 02-Oct-08 N/A N/A 2645 8703 SN081017 Naviscan PEM Flex Solo II PET Scanner FDA Z-2229-2008 Class II 02-Oct-08 N/A N/A SN081018 Biogenex Laboratories Xmatrx FISH Automated Staining System FDA Z-1471-2008 Class II 02-Oct-08 N/A N/A SN081019 Abbott Total Bilirubin MHRA 2008/009/018/601/005 FSCA 02-Oct-08 Abbott Laboratories Ltd. 2806 4021 SN081020 Immucor Galileo Echo MHRA 2008/009/022/061/013 FSCA 02-Oct-08 N/A N/A SN081021 ConMed VCareR Uterine Manipulators MHRA 2008/009/002/061/001 FSCA 02-Oct-08 N/A N/A SN081022 Sendal 3101-TJ Transfusion Set MHRA 2008/009/011/061/010 FSCA 02-Oct-08 N/A N/A Medical Device Control Office 15 Department of Health The Government of HKSAR SN081023 Diagnostica Stago (STA) Neoplastine CI (Plus) 10 MHRA 2008/009/025/061/010 FSCA 02-Oct-08 Healthpro Technology Co. Ltd N/A SN081024 Spacelabs Ultraview Digital Telemetry Reciever, model 90478 MHRA 2008/008/014/061/012 FSCA 02-Oct-08 N/A N/A SN081025 ThermoFisher Tryptone soya broth BO0351G MHRA 2008/009/023/601/003 FSCA 02-Oct-08 N/A N/A SN081026 Nebion, LLC HLX-8 Magnetic Resonance Device FDA N/A Class I 06-Oct-08 N/A N/A SN081027 Kimal K-Flow access catheters MHRA 2008/008/026/401/004 FSCA 06-Oct-08 N/A N/A SN081028 Draeger Zeus Anaesthetic machines software version 4.01 MHRA 2008/009/015/051/009 FSCA 06-Oct-08 Draeger Medical Hong Kong Ltd. 2877 3077 SN081029 GENICON 5 mm Pyramidal Trocars MHRA 2008/009/026/061/009 FSCA 06-Oct-08 N/A N/A SN081030 GE Healthcare Aisys Anaesthesia machine MHRA 2008/009/025/061/011 FSCA 06-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081031 Remploy Access and Accent attendant propelled wheelchairs MHRA MDA/2008/070 MDA 08-Oct-08 N/A N/A SN081032 Park House Alternating air mattress pumps models PHP198,396, 398 and 399 MHRA MDA/2008/071 MDA 08-Oct-08 N/A N/A SN081033 Hoggi BINGO Rehab Pushchair MHRA 2008/005/030/061/019 FSCA 08-Oct-08 N/A N/A SN081034 Sunrise Medical Breezy Moonlite Wheelchairs MHRA 2008/005/028/401/006 FSCA 08-Oct-08 N/A N/A SN081035 Hologic: ATEC 1212-20 Handpieces MHRA 2008/009/026/061/014 FSCA 09-Oct-08 N/A N/A SN081036 ThermoFisher Columbia Blood Agar, PB0122A MHRA 2008/010/002/601/002 FSCA 09-Oct-08 N/A N/A SN081037 Siemens Medical Solutions Diagnostics ADVIA Chemistry Controls 1 and 2 MHRA 2008/010/001/061/008 FSCA 09-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081038 Abbott ClearStar model number M771 MHRA 2008/010/001/061/012 FSCA 09-Oct-08 Abbott Laboratories Ltd. 2806 4021 SN081039 Baxter FLOGARD 6201 Volumetric Infusion Pump (Product Code 2M8063) Baxter Healthcare Ltd N/A Firm Initiated Field Action 10-Oct-08 Baxter Healthcare Ltd 2807 8500 SN081040 NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator FDA Z-0071-2008 Class II 13-Oct-08 N/A N/A SN081041 GE Healthcare OEC 9900 mobile fluoroscopic x-ray system FDA Z-0368-2008 Class II 13-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081042 GE Healthcare Innova 3100 and 4100 Digital Fluoroscopic Imaging System with Bolus Chasing FDA Z-1516-2008 to Z-1517-2008 Class II 13-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1547-2008 Class II 13-Oct-08 N/A N/A FDA Z-1692-2008 Class II 13-Oct-08 COVIDEN 3157 7220 SN081043 SN081044 ev3" 55442-2920, sterile EO, single Use, Visi-Pro BalloonExpandable Peripheral Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802 SN081045 Toshiba America Medical Systems (TAMS) Aquilion 32 CT and 64 CT system, computed tomography x-ray system FDA Z-1707-2008 to Z-1708-2008 Class II 13-Oct-08 Sanko Medical Systems (HK) Ltd. 2384 0688 SN081046 Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system FDA Z-1751-2008 Class II 13-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081047 Siemens Medical Solutions, Mevatron Digital Linear Accelerator FDA Z-1753-2008 to Z-1763-2008 Class II 13-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081048 X-STOP Interspinous Process Decompression (lPD) System FDA Z-1765-2008 Class II 13-Oct-08 N/A N/A Medical Device Control Office 16 Department of Health The Government of HKSAR SN081049 GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis FDA Z-2183-2008 Class II 13-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081050 Cook Vital Port Vascular Access System Polysulfone Petite FDA Z-2190-2008 to Z-2191-2008 Class II 13-Oct-08 Cook Asia (Hong Kong) Ltd. 2781 0232 SN081051 Brainlab VectorVision (VV) Sky Navigation Platform FDA Z-2209-2008 Class II 13-Oct-08 BrainLAB Ltd. (Hong Kong) FDA Z-2213-2008 to Z-2214-2008 Class II 13-Oct-08 N/A N/A FDA Z-2219-2008 to Z-2224-2008 Class II 13-Oct-08 N/A N/A FDA Z-2235-2008 Class II 13-Oct-08 Philips Healthcare - Great China 2821 5480 SN081052 SN081053 SN081054 Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base Applied Medical Silhouette Xtraflo Device with SL-6 Hydrophilic Coating Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System SN081055 Abaxis, Inc.Piccolo Chemistry Analyzer software version 6.121 FDA Z-2286-2008 to Z-2287-2008 Class II 13-Oct-08 N/A N/A SN081056 Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System FDA Z-2307-2008 Class II 13-Oct-08 Philips Healthcare - Great China 2821 5480 SN081057 Varian Medical Systems Eclipse device, model H48, Version 6.5 FDA Z-2308-2008 Class II 13-Oct-08 Varian Medical Systems Pacific Inc. 2724 2836 FDA Z-2329-2008 Class II 13-Oct-08 N/A N/A FDA Z-2347-2008 Class II 13-Oct-08 N/A N/A SN081058 SN081059 SCC Soft Computer SoftPath GUI Release Software Versions 3.17 and 4.1 Kyphon KyphX Osteo Introducer System with blunt tip introducer stylet SN081060 Steris Small Renaissance Eagle 3000 FDA Z-2350-2008 Class II 13-Oct-08 N/A N/A SN081061 Boston Scientific Platinum Plus Guidewire FDA Z-2362-2008 to Z-2365-2008 Class II 13-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 SN081062 BD Ace Heat Therapy FDA Z-2431-2008 Class II 13-Oct-08 N/A N/A SN081063 Zimmer Universal Optical Tracker Fixation, not sterile, REF 111.031 FDA Z-2445-2008 Class II 13-Oct-08 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN081064 Smith & Nephew Caption Disposable Platelet Concentrator Kit Ref 71178200 and Ref 71178202 FDA Z-2446-2008 to Z-2447-2008 Class II 13-Oct-08 Smith & Nephew Limited SN081065 Siemens SOMATOM Emotion 6 and Emotion 16 Computed tomography X-ray system FDA Z-2452-2008 to Z-2453-2008 Class II 13-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081066 ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500 FDA Z-2458-2008 Class II 13-Oct-08 N/A N/A SN081067 American Medical 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232 FDA Z-2461-2008 Class II 13-Oct-08 N/A N/A SN081068 SCC SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3 FDA Z-2463-2008 Class II 13-Oct-08 N/A N/A SN081069 BD Anaesthesia Kits and Epidural Filter MHRA 2008/010/006/061/006 FSCA 14-Oct-08 BD Asia Ltd (Hong Kong) 2575 8668 SN081070 GE Healthcare Advantage Workstation Suite-Card IQ MHRA 2008/010/006/061/010 FSCA 14-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 2645 8703 SN081071 GE Healthcare AMX Series Mobile RAD System(AMX 4 and AMX 4+ MHRA 2008/010/002/061/004 FSCA 14-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081072 Thomas Medical Products SafetSheath family MHRA 2008/009/029/061/018 FSCA 14-Oct-08 N/A N/A SN081073 ThermoFisher Xpect Giardia/ Cryptosporidium Kit MHRA 2008/008/014/061/008 FSCA 14-Oct-08 N/A N/A SN081074 CASMED 500cc Single Patient Use Infusion Cuffs MHRA 2008/010/001/061/001 FSCA 14-Oct-08 N/A N/A SN081075 Boston Scientific Atlantis PV 15 MHz Imaging Catheter Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 15-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 Medical Device Control Office 17 Department of Health The Government of HKSAR Boston Scientific Hong Kong Ltd Medtronic International Ltd N/A Firm Initiated Field Action Firm Initiated Field Action 15-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 15-Oct-08 Medtronic International, Ltd. 2907 5911 Class II 16-Oct-08 N/A N/A Z-1931-2008 to Z-2001-2008 Class II 16-Oct-08 N/A N/A FDA Z-1896-2008 to Z-1900-2008 Class II 16-Oct-08 N/A N/A ArthroCare ArthroWand Covator with Integrated Cable Wand (Catalog no AC4340-01) FDA Z-2309-2008 Class II 16-Oct-08 ArthoCare Asia Pacific 2159 7436 SN081082 Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00 FDA Z-2314-2008 Class II 16-Oct-08 N/A N/A SN081083 Propper short gas-chex EO sterilization indicators (Recorder no 269001) FDA Z-2330-2008 Class II 16-Oct-08 N/A N/A SN081084 Oscor Permanent Pacing Lead FDA Z-2333-2008 Class II 16-Oct-08 N/A N/A SN081085 Smiths Medical Deltec 3000 Large Volume Infusion Pump and Deltec Micro 3100 Large Volume Infusion Pump FDA Z-1604-2008 to Z-1605-2008 Class II 16-Oct-08 N/A N/A SN081086 Nova Biomedical Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) FDA Z-1472-2008 Class II 16-Oct-08 N/A N/A SN081087 Stryker Rejuvenate Broach FDA Z-2349-2008 Class II 16-Oct-08 Stryker China Ltd 2518 6988 FDA Z-2007-2008 Class II 16-Oct-08 Stryker China Ltd 2518 6988 FDA Z-2310-2008 Class II 16-Oct-08 AMO Asia Limited 2480 3330 FDA Z-2305-2008 Class II 16-Oct-08 Abbott Laboratories Ltd. 2806 4021 FDA Z-2212-2008 Class II 16-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081076 Boston Scientific Excelsior SL-10 Microcatheter SN081077 Medtronic (Physio-Control) LIFEPAK CR Plus defibrillator/ LIFEPAK EXPRESS defibrillator SN081078 Acumed Locking Tarsometatarsal Plate, Locking Proximal Metatarsal Wedge Plate, Locking Clavicle Plate FDA Z-2108-2008 to Z-2132-2008 SN081079 Portland Orthopaedics Margron DTC Hip Replacement System FDA SN081080 Curlin Medical Model 2000, 4000 and 600 CMS/ Plus Ambulatory Infusion Pump, PainSmart, PainSmart IOD Ambulatory Infusion System SN081081 SN081088 SN081089 Stryker 6.5 Cancellous Bone Screw 25mm (Catalog No 2030-65251) AMO WaveScan WaveFront System Version 3.90/3.901 (Part No. 0070-1478) SN081090 Abbott Flexiflo Quantum Pump Set (List # 50604) SN081091 SN081095 Siemens Acuson CV70 Ultrasound Systems Medtronic SPECIFY 3998 Lead Kit for Spinal Cord Stimulation (SCS) GE Innova 3100/3100IQ, 2100IQ, 4100/4100IQ, Advantx-E, Innova 2121-1Q/2121-1Q and Innova 2000 GE Precision RXi Digital remote X-Ray Imaging R&F System (model 5117828) GE Definium 800 Digital Radiographic System (Model 5135678) SN081096 SN081092 N/A FDA Z-2241-2008 Class II 16-Oct-08 Medtronic International, Ltd. 2907 5911 FDA Z-2356-2008 to Z-2361-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-2145-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1883-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 GE Datex-Ohmeda Engstrom Carestation FDA Z-1829-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081097 GE Proteus XR/a Eclipse Collimator (Model # 2379827) FDA Z-1713-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081098 GE Precision 500D and Advantx Legacy Radiographic and Fluoroscopic systems FDA Z-1610-2008 to Z-1611-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081099 GE Innova 3100 Digital Fluoroscopic Imaging and Innova 4100 Digital Fluoroscopic Imaging FDA Z-1521-2008 to Z-1522-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN0810100 GE OEC 9800 Fluoroscopic X-Ray System and OEC 9900 Elite Fluoroscopic X-Ray System FDA Z-1885-2008 Class II 16-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN0810101 Siemens Dimension Clinical Chemistry System - Enzymatic Creatinine Flex Reagent Cartridge DF270 MHRA 2008/010/007/061/010 FSCA 17-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN081093 SN081094 Medical Device Control Office 18 Department of Health The Government of HKSAR SN0810102 Spacelabs Healthcare 90496 and 91496 Command Module NIBP Option MHRA 2008/010/003/061/005 FSCA 17-Oct-08 N/A N/A SN0810103 Johnson & Johnson Biosense Webster NAVISTAR RMT 4mm, 8nn DS and THERMOCOOL Catheters MHRA 2008/010/009/061/005 FSCA 17-Oct-08 Johnson & Johnson Medical (HK) 2738 6027 SN0810104 Varian C-Series Clinac Linear Accelerator Health Canada 44028 Type I 17-Oct-08 Varian Medical Systems Pacific Inc. 27242836 SN0810105 Varian Acuity, Ximatron Health Canada 43747 Type I 17-Oct-08 Varian Medical Systems Pacific Inc. 27242836 SN0810106 Immucor Galileo / Capture-R Ready test wells Health Canada 43677 Type I 17-Oct-08 N/A N/A SN0810107 Immucor Galileo Echo / CaptureR Ready Scrn strip Health Canada 43678 Type I 17-Oct-08 N/A N/A SN0810108 Ferno 35-A Mobile Transporter Health Canada 43920 Type II 17-Oct-08 Goodman Medical Supplies Ltd 2332 4455 SN0810109 Anspach effort A) 12.6mm Boring Tool, B) 9.5mm Boring Tool Health Canada 43458 Type II 17-Oct-08 N/A N/A SN0810110 Cardinal Health Custom Sterile Procedure Pack Health Canada 43591 Type II 17-Oct-08 N/A N/A SN0810111 Sirona Dental System GMBH Galileos 3D X-Ray with Galaxis 1.5 Health Canada 43380 Type II 17-Oct-08 N/A N/A SN0810112 Siemen Axiom Artis, Axiom Artis DMP Health Canada 43745 Type II 17-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN0810113 Roche Cobas Integra System-Smphetamines, Roche Hitachi-Online Amphetamines Health Canada 43716 Type II 17-Oct-08 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN0810114 Welch Allyn Fiber Optic Sigmoidoscope, Insufflation Bulbs Health Canada 43629 Type II 17-Oct-08 Ultronics Enterprises Ltd 2764 5208 SN0810115 Cybernius Medical Nepfrocare Software Health Canada 43736 Type II 17-Oct-08 N/A N/A SN0810116 Biomerieux Oberva Data Management System Health Canada 42986 Type II 17-Oct-08 Biomerieux China Ltd (HK) 2356 7033 SN0810117 Stryker Communication Ophit DVI Extender Health Canada 43879 Type II 17-Oct-08 Stryker China Ltd 2518 6988 SN0810118 Immco Diagnostic West Nile Virus IGG Indirect Elisa Health Canada 43722 Type II 17-Oct-08 N/A N/A SN0810119 Griener Bio One Vacuette Lithium Heparin Blood Collection Tube Health Canada 43583 Type II 17-Oct-08 Mekim Ltd 2774 8300 Bausch & Lomb (Hong Kong) Limited N/A Firm Initiated Field Action 21-Oct-08 Bausch & Lomb (Hong Kong ) Ltd 2213 3371 SN0810120 SN0810121 SN0810122 Bausch & Lomb Medalist Toric (SofLens 66 Toric) Contact Lenses (Lot no. W64067390, W64067389, W64067246) and Medalist One Day Plus, SofLens daily disposable (hilaflcon B) Visibility Tinted Contact Lenses (Lot no X10050809A and R10050805A) ThermoFisher EB0212E, Cooked meat medium, lot number 1048169 Qualigen Fast Pack Total PSA Lot 0807002 MHRA 2008/010/007/601/002 FSCA 23-Oct-08 N/A N/A MHRA 2008/010/010/061/004 FSCA 23-Oct-08 N/A N/A SN0810123 Orasure Oral Fluid Positive Control, Oral Fluid Negative Control, Oral Fluid Cutoff Calibrator MHRA 2008/010/010/061/006 FSCA 23-Oct-08 N/A N/A SN0810124 Radiometer ABL700 Series Calibration 1 Solution MHRA 2008/009/008/061/002 FSCA 23-Oct-08 N/A N/A N/A SN0810125 Nucletron Oncentra Prostate System (with option CT/MRI imaging) MHRA 2008/006/027/401/003 FSCA 23-Oct-08 N/A SN0810126 BD Vacutainer Blood Collection Tubes MHRA 2008/009/006/601/001 FSCA 23-Oct-08 BD Asia Ltd (Hong Kong) Homecraft Rolyan 2” and 4” Savanah raised toilet seats MHRA MDA/2008/075 MDA 24-Oct-08 N/A N/A MHRA MDA/2008/076 MDA 24-Oct-08 N/A N/A 24-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 24-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 27-Oct-08 Swedish Trading Co., Ltd SN0810127 SN0810128 SN0810129 Lomax Mobility Kid Active folding manual wheelchair with swing away footrests Boston Scientific TruPath Biopsy Device and easy Core Biopsy Device SN0810130 Boston Scientfic easyCore Biopsy System (Endoscopy) SN0810131 Steris Quick Connect component (p/n 201048) Medical Device Control Office Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd FDA N/A N/A Z-2462-2008 19 Firm Initiated Field Action Firm Initiated Field Action Class II Department of Health The Government of HKSAR SN0810132 Philips Ultraview Digital Telemetry Transmitter (Model 91341-09) FDA Z-2336-2008 Class II 27-Oct-08 Philips Healthcare - Great China 2821 5480 SN0810133 Zimmer Quicklock Tracker (Size 2, Ref 111.100) Sunrise Medical Quickie Groove Power Wheelchair with Transit option Biomet Exact Calcar Planer Rasp Style Blade (REF 31-473795 to 31-473798) FDA Z-2444-2008 Class II 27-Oct-08 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 FDA Z-2339-2008 Class II 27-Oct-08 N/A N/A FDA Z-2370-2008 to Z-2373-2008 Class II 27-Oct-08 N/A N/A SN0810134 SN0810135 SN0810136 Cardinal Health NicoletOne photic adapter cable 085-463700 FDA Z-2389-2008 Class II 27-Oct-08 Cardinal Health SN0810137 Angiodynamics Centros Chronic Hemodialysi Curved Catheter Set (Catalog no./REF 10303101 to 10303103) FDA Z-2396-2008 to Z-2398-2008 Class II 27-Oct-08 N/A N/A SN0810138 Arjo Kwiktrak Gate System FDA Z-2434-2008 Class II 27-Oct-08 Arjo Huntleigh (Hong Kong) Ltd 2508 9553 SN0810139 B. Braun Horizon Pump Set, Adult Metriset, Safeline Metriset, Metriset Burette Set, Burette Set, Add-On Burette Set FDA Z-2407-2008 to Z-2414-2008 Class II 27-Oct-08 B Braun Medical Hong Kong 2277 6125 SN0810140 ACIST BRACCO AT P54 AngioTouch Kit FDA Z-2406-2008 Class II 27-Oct-08 Pacific Medical (Hong Kong) Ltd. 2343 8009 2240 6150 SN0810142 Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part No. 472169) Cardinal Health NicoletOne 5.30.2 Software SN0810143 Boston Scientific easy Core Biopsy Device (Peripheral Interventions) SN0810144 Baylis Medical BMC RF Cannula - Part # PMF20-100-10CS; Lot PFFA211107 MHRA 2008/010/002/061/003 FSCA 27-Oct-08 N/A N/A SN0810145 GE Healthcare Giraffe and Panda Warmers MHRA 2008/010/014/601/001 FSCA 27-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 MHRA 2008/010/016/061/016 FSCA 27-Oct-08 Medtronic International, Ltd. 2919 1300 MHRA 2008/008/018/301/001 FSCA 27-Oct-08 N/A N/A FDA N/A Press Release 27-Oct-08 N/A N/A 2008/010/010/061/012 FSCA 28-Oct-08 N/A N/A SN0810141 FDA Z-2405-2008 Class II 27-Oct-08 Beckman Coulter Hong Kong Ltd FDA Z-2459-2008 Class II 27-Oct-08 Cardinal Health Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 27-Oct-08 Boston Scientific Hong Kong Ltd 2960 7136 SN0810146 Medtronic OptiVol CareAlert and CareLink Transmissions Issue SN0810147 Invacare Typhoon 1 & 2 Power Wheelchairs SN0810148 Thoratec HeartMate II LVAS SN0810149 Helena Laboratories Manual D-dimer 5250 MHRA SN0810150 Metrax Primedic DefiMonitor XD Series MHRA 2008/010/006/061/011 FSCA 29-Oct-08 N/A N/A SN0810151 Tryton Side Branch Stent MHRA 2008/010/014/061/023 FSCA 29-Oct-08 N/A N/A SN0810152 Inverness Panbio West Nile Virus IgM Capture ELISA MHRA 2008/010/022/061/008 FSCA 29-Oct-08 N/A N/A SN0810153 Biomet 2.00mm Crimp Sleeve, item: 350805, lot 568400 MHRA 2008/010/013/601/004 FSCA 29-Oct-08 N/A N/A SN0810154 Edwards Lifesciences Vigilance II Monitor VIG2/VIG2E MHRA 2008/010/010/061/011 FSCA 29-Oct-08 N/A N/A SN0810155 Stryker Circlip retaining system MHRA 2008/010/009/061/007 FSCA 29-Oct-08 Stryker China Ltd 2518 6988 2518 6988 SN0810156 Stryker System 6 and Cordless Driver 3 Handpiece MHRA 2008/010/015/061/013 FSCA 29-Oct-08 Stryker China Ltd SN0810157 Respironics BIPAP Focus Ventilator System MHRA 2008/010/009/061/028 FSCA 29-Oct-08 CELKI Medical Company SN0810158 Siemens IMMULITE® 2000/2500 Substrate Module L2SUBM 252 MHRA 2008/010/023/061/015 FSCA 29-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN0810159 DLS Medical Wound dressing pack avm3550, Woundcare pack avm3633, Basic care pack avm3757 MHRA 2008/009/026/601/002 FSCA 30-Oct-08 N/A N/A SN0810160 BRAHMS PAPP-A Kryptor Lots 566034 and 566036 MHRA 2008/010/010/061/007 FSCA 30-Oct-08 N/A N/A SN0810161 Ergolet Luna Track Hoist Handset MHRA 2008/004/004/401/002 FSCA 30-Oct-08 N/A N/A SN0810162 Sidhil Universal Standard and High Siderails MHRA 2008/008/018/401/004 FSCA 30-Oct-08 N/A N/A SN0810163 R82 X-Panda size 2 High-Low Frame MHRA 2008/004/025/401/012 FSCA 30-Oct-08 N/A N/A SN0810164 Spacelabs Healthcare Ultraview SL Command Module (Model 90496 and 91496) FDA Z-2342-2008 to Z-2343-2008 Class II 30-Oct-08 N/A N/A Medical Device Control Office 20 Department of Health The Government of HKSAR SN0810165 Zimmer Durom cup, Metasul Durom acetabular compenent FDA Z-2415-2008 to Z-2426-2008 Class II 30-Oct-08 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN0810166 Medtronic BI-700-00027 0-arm 1000 Imaging System mobile X-ray System FDA Z-2034-2008 Class II 30-Oct-08 Medtronic International, Ltd. 2907 5911 SN0810167 Siemens Sonoline G50/G60 Ultrasound System (Software versions 1.0.0 to 1.5.0b) FDA Z-2468-2008 Class II 30-Oct-08 Siemens Healthcare Diagnostic Limited 2810 7533 SN0810168 GE Precision MPi (Model 5126893 -, 2385125, 2398238) FDA Z-2142-2008 to Z-2144-2008 Class II 30-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SN0810169 GE Healthcare Innova 2100IQ, 3100 IQ, 4100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular FDA Z-1518-2008 to Z-1520-2008 Class II 30-Oct-08 GE Medical Systems Hong Kong Ltd. 2783 1838 Medical Device Control Office 21 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - September 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SN080901 Invacare Reliant 100 / 150 / 200 / 250 MHRA 2008/001/008/401/008 FSCA 2008/09/02 N/A N/A SN080902 Sybron Pitt Easy implants MHRA 2008/008/019/061/013 FSCA 2008/09/02 N/A N/A SN080903 Liftech Gemini Ceiling Track Hoist MHRA 2008/006/011/291/006 FSCA 2008/09/02 N/A N/A 2008/09/03 Boston Scientific HK Limited 2960 7136 2008/09/03 Medtronic International, Ltd. 2907 5911 SN080904 Boston Scientific Platinum PlusT Guidewire (Peripheral) SN080905 Medtronic Adjustable Valve Model 6248VAL and Attain 6216A and 6218A System Kits SN080906 Physio Control LIFEPAK CR Plus SN080907 Boston Scientific Hong Kong Ltd Medtronic International Ltd N/A N/A Firm Initiated Field Action Firm Initiated Field Action Medtronic International Ltd N/A Firm Initiated Field Action 2008/09/03 Medtronic International, Ltd. 2907 5911 Ev3 Primus GPS Biliary Stent Systems (Ref: BXB35-08-37-75) FDA Z-2170-2008 Class II 2008/09/04 N/A N/A SN080908 Ev3 Protege GPS Biliary Stent Systems (Ref: SERB65-06-60-120) FDA Z-2169-2008 Class II 2008/09/04 N/A N/A SN080909 Arjo Nautica (GK) Mattress Stretcher FDA Z-1234-2008 Class II 2008/09/04 Arjo Huntleigh (Hong Kong) Ltd 2508 9553 SN080910 Smiths Medical CADD-MS"3 Ambulatory Infusion Pumps (Model 7400, Rx only) FDA Z-1641-2008 Class II 2008/09/04 Goodman Medical Supplies Ltd 2332 4455 SN080911 Philips Medical General X-Ray System types with Digital Spot Imaging (DSI) software (Software version: rel 6) FDA Z-2160-2008 Class II 2008/09/04 Philips Healthcare - Great China 2821 5480 SN080912 Stryker Stem Trial, Triathlon Revision Instruments FDA Z-2157-2008 to Z-2158-2008 Class II 2008/09/04 Stryker China Ltd 2518 6988 SN080913 Stryker Xcelerate Patella System Reamer Shaft Assembly (Product no.: 8001-1702) FDA Z-1778-2008 Class II 2008/09/04 Stryker China Ltd 2518 6988 SN080914 Medtronic Midas Rex Legend tapered dissecting tool (Model F2/8TA23) FDA Z-2156-2008 Class II 2008/09/04 Medtronic International, Ltd. 2907 5911 SN080915 Medtronic Physio Control, FASTPAK batteries FDA Z-1567-2008 Class II 2008/09/04 Medtronic International, Ltd. 2907 5911 SN080916 GE Healthcare Corometrics Model 250 series Maternal/ Fetal Monitor (Models 256 and 259, part no 2024489-002) FDA Z-2154-2008 Class II 2008/09/04 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080917 GE Healthcare Precision RXi 23A/32A Remote X-Ray Imaging R&F System FDA Z-1563-2008 to Z-1565-2008 Class II 2008/09/04 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080918 Siemens Medical Syn go Imaging XS (Model no 7502029) FDA Z-1643-2008 Class II 2008/09/04 Siemens Ltd. 2810 7533 SN080919 Hill-Rom Century+ Bed (Model P1400 HBSM siderail upgrade kits) FDA Z-1777-2008 Class II 2008/09/04 N/A N/A SN080920 Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement FDA Z-1696-2008 to Z-1697-2008 Class II 2008/09/04 N/A N/A SN080921 Acumed 3.5mm x 32.5mm Cortical Screw used with the Polarus Humeral Fixation System FDA Z-2155-2008 Class II 2008/09/04 N/A N/A SN080922 Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B (Part no 793080-002) FDA Z-2201-2008 Class II 2008/09/04 N/A N/A SN080923 Pride Mobility Q-Logic Controller Software FDA Z-1776-2008 Class II 2008/09/04 N/A N/A Medical Device Control Office 22 Department of Health The Government of HKSAR Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/09/05 Boston Scientific HK Limited 2960 7136 Genzyme Seprafilm Adhesion Barrier (Product Number: 4301-02 and 4301-05) FDA Z-1647-2008 to Z-1648-2008 Class II 2008/09/08 Genzyme Asia Limited 2810 1613 SN080926 Sunrise Medical Quickie Rhythm Power Wheelchair with QC (nonexpandable) electronics (Model no. EIPW10 and EIPW13) FDA Z-1531-2008 to Z-1532-2008 Class II 2008/09/08 N/A N/A SN080927 Caire Generation 4 electronic liquid gauges FDA Z-1716-2008 Class II 2008/09/08 N/A N/A SN080928 Huntleigh Healthcare Maxisky 600 MHRA 2007/010/018/401/014 FSCA 2008/09/08 N/A N/A SN080929 Peacocks Medical Fitzyou Moulded Wheelchair seat Systems MHRA 2007/010/016/261/001 FSCA 2008/09/08 N/A N/A SN080930 Invacare Scanbed SB750 MHRA 2007/011/015/061/004 FSCA 2008/09/08 N/A N/A SN080931 Abbott Universal Clamp Reduction Tool MHRA 2008/008/014/061/004 FSCA 2008/09/09 Abbott Laboratories Ltd. 2806 4021 SN080932 GE Healthcare Signa HDx Scanner MHRA 2008/008/027/061/019 FSCA 2008/09/09 GE Medical Systems HK Ltd 2783 1838 SN080933 Intersurgical Solus Laryngeal Mask Airway MHRA 2008/008/027/061/028 FSCA 2008/09/09 N/A N/A SN080934 Johnson and Johnson Cordis LuMend Outback Re-entry catheter MHRA 2008/008/021/061/008 FSCA 2008/09/09 Johnson & Johnson Medical (HK) 2738 6027 SN080935 Bausch & Lomb AMVISC and AMVISC PLUS - Viscoelastic (Ref: DV-2007-8041) Bausch & Lomb (Hong Kong) Limited N/A Firm Initiated Field Action 2008/09/10 Bausch & Lomb (Hong Kong ) Ltd 2213 3371 SN080936 Innovacon Prostate Specific Antigen MHRA 2008/008/029/061/022 FSCA 2008/09/10 N/A N/A SN080937 Drager Primus, Apollo, Pallas Devices MHRA 2008/008/029/061/020 FSCA 2008/09/10 Draeger Medical Hong Kong Ltd. 2877 3077 SN080938 STERIS 20 Sterilant Concentrate MHRA 2008/007/015/401/008 FSCA 2008/09/10 Swedish Trading Co. Ltd. N/A SN080939 Gambro SteriChek Sensitive Total Chlorine Reagent Strips MHRA 2008/008/012/061/011 FSCA 2008/09/11 Gambro Hong Kong Limited N/A SN080940 Medtronic Neurostimulator programmers MHRA MDA/2008/065 MDA 2008/09/12 Medtronic International, Ltd. 2907 5911 SN080941 Edwards Lifesciences Ascendra Balloon Catheter MHRA 2008/008/027/061/007 FSCA 2008/09/12 N/A N/A SN080942 Sirona type B, VS and S Siroclaves and Siromini MHRA 2008/009/002/061/004 FSCA 2008/09/12 N/A N/A SN080943 Boston Scientific ALTRUA® Implantable Pacemaker MHRA 2008/009/003/061/007 FSCA 2008/09/12 Boston Scientific HK Limited 2960 7136 SN080944 GE Precision 500D Classical Radiographic-Fluoroscopic X-Ray System (Model# 2289299-2) FDA Z-0369-2008 Class II 2008/09/12 GE Healthcare 2609 9233 SN080945 Abbott InCompass Spinal Fixation System T-Handle Driver and PathFinder Spinal Fixation System T-Handle Driver FDA Z-1592-2008 to Z-1593-2008 Class II 2008/09/12 Abbott Laboratories Ltd. 2806 4021 SN080946 Otsuka UBiT®-IR300 Infrared Spectrophotometer, software versions 7.0, 7.01 and 7.11 FDA Z-1749-2008 Class II 2008/09/12 Otsuka Pharmaceutical (HK) Ltd 2881 6299 2008/09/12 Goodwin Health Care Ltd N/A SN080924 Bostson Scientific Smash Balloon Dilatation Catheter SN080925 Goodwin Health Care Ltd SN080947 Invivo Lithium Polymer Wireless Module Batteries SN080948 Teleflex Weck Clips products : Hemolok clips, Horizon Clips and Hemoclip Solar-med Limited N/A 2008/09/12 Solar-med Limited 2425 0926 SN080949 Vital Signs Light Wand Orotracheal Lighted Stylet MHRA 2008/008/028/061/002 FSCA 2008/09/16 N/A N/A SN080950 Cook Zenith AAA Stent-Graft MHRA 2006/005/017/401/009 FSCA 2008/09/16 Cook Asia Ltd N/A SN080951 Philips Healthcare iSite PACS MHRA 2008/008/026/061/019 FSCA 2008/09/16 Philips Healthcare - Great China 2821 5480 Medical Device Control Office N/A Firm Initiated Field Action Firm Initiated Field Action 23 Department of Health The Government of HKSAR SN080952 ThermoFisher BO0366D Brain Heart Infusion MHRA 2008/009/002/601/004 FSCA 2008/09/16 N/A N/A SN080953 R82 A/S Hip Belt MHRA 2008/009/005/061/006 FSCA 2008/09/16 N/A N/A SN080954 Philips Healthcare HDI4000 Diagnostic Ultrasound System MHRA 2008/009/010/061/004 FSCA 2008/09/16 Philips Healthcare - Great China 2821 5480 SN080955 Philips Healthcare HD3 Diagnostic Ultrasound System MHRA 2008/009/010/061/010 FSCA 2008/09/16 Philips Healthcare - Great China 2821 5480 SN080956 SN080957 BD FACSAria Sorters running BD FACSDiva Software, version 3.0 or later Johnson and Johnson ASP Automatic Endoscope Reprocessor (AER) BD Asia Ltd (Hong Kong) Johnson & Johnson Medical Hong Kong Boston Scientific Hong Kong Ltd N/A N/A 2008/09/16 BD Asia Ltd (Hong Kong) 2575 8668 2008/09/16 Johnson & Johnson Medical (HK) 2738 6027 2008/09/17 Boston Scientific HK Limited 2960 7136 SN080958 Boston Scientific iLabR Ultrasound Imaging Systems SN080959 GE Healthcare Responder 2000 Defibrillator MHRA 2008/008/013/061/012 FSCA 2008/09/18 GE Medical Systems HK Ltd 2783 1838 SN080960 Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts MHRA MDA/2008/066 MDA 2008/09/19 Stryker China Limited 2518 6988 SN080961 MHRA 2008/009/010/061/008 FSCA 2008/09/19 Philips Healthcare - Great China 2821 5480 FDA Z-2192-2008 to Z-2193-2008 Class II 2008/09/19 Abbott Laboratories Ltd. 2806 4021 SN080963 Philips Healthcare BV Pulsera and Endura Abbott AGA Medical Corporation AMPLATZER Delivery System (REF 9-DEL-10F-45/80) and AMPLATZER Sizing Balloon II (REF 9SB 24) Abbott Free Style Blood Glucose Monitoring System Test Strips FDA Z-1813-2008 Class II 2008/09/19 Abbott Laboratories Ltd. 2806 4021 SN080964 Abbott PathFinder Cannulated T-Handle Bone Awl (Part No. 1155-2) FDA Z-1784-2008 Class II 2008/09/19 Abbott Laboratories Ltd. 2806 4021 FDA Z-1526-2008 Class II 2008/09/19 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1825-2008 Class II 2008/09/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080962 SN080965 SN080966 GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation N/A Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action SN080967 Medtronic CD Horizon Agile Dynamic Stabilization Device FDA Z-1408-2008 to Z-1441-2008 Class II 2008/09/19 Medtronic International, Ltd. 2907 5911 SN080968 Medtronic Physio-Control LIFEPAK 20 and LIFEPAK 20e Difibrillator/monitor FDA Z-2009-2008 to Z-2011-2008 Class II 2008/09/19 Medtronic International, Ltd. 2907 5911 SN080969 Medtronic Suction Jar Lid for Medela Vario 18 Vacuum Pump FDA Z-2168-2008 Class II 2008/09/19 Medtronic International, Ltd. 2907 5911 SN080970 GE 1.5 T and 3.0 T Signa HDX MR System Model No. 2226300, 2377062-61, 2395001, 2395001-2, 5107849 and 5127452 FDA Z-2225-2008 Class II 2008/09/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080971 Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1 FDA Z-1768-2008 Class II 2008/09/19 Siemens Ltd. 2810 7533 SN080972 Siemens SIMIVIEW 3000, SIMVIEW NT and MEV ASIM S systems (Instructions" TH003/08/S" update) FDA Z-2196-2008 Class II 2008/09/19 Siemens Ltd. 2810 7533 SN080973 Stryker Scorpio Total Knee Posteriorly Stabilized Femoral Component #7R and #7l (Catalog # 71-4107R and 71-4506L) FDA Z-1814-2008 Class II 2008/09/19 Stryker China Ltd 2518 6988 SN080974 Stryker Gamma3 System Set Screwdriver, Flexible Shaft and Gammas Set Screwdriver Instrument Set, Orthopedic Device FDA Z-1626-2008 to Z-1627-2008 Class II 2008/09/19 Stryker China Ltd 2518 6988 SN080975 Stryker Digital System Ultra (SDC Ultra) (Model no.: 240-050-988) FDA Z-1316-2008 Class II 2008/09/19 Stryker China Ltd 2518 6988 SN080976 Covidien/Mallinckrodt CT9000/ CT9000ADV (Model no.: 241300) FDA Z-1828-2008 Class II 2008/09/19 COVIDIEN 3157 7220 SN080977 Biomet EZLoc 7-8mm TM Femoral Fixation (Catalog No 904780) FDA Z-1782-2008 Class II 2008/09/19 N/A N/A SN080978 Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter (Part number 31-555610) FDA Z-1318-2008 Class II 2008/09/19 N/A N/A Medical Device Control Office 24 Department of Health The Government of HKSAR SN080979 Varian Medical Varis Aria Radiation Oncology Version 8.1 FDA Z-2194-2008 Class II 2008/09/19 Varian Medical Systems Pacific Inc. 2724 2836 SN080980 Telefex Weck - DuraHook (Catalog #382800, 382805) FDA Z-1856-2008 to Z-1857-2008 Class II 2008/09/19 Solar-med Limited 2425 0926 SN080981 AGFA IMPAX 6.2.1 System (PAC) FDA Z-1245-2008 Class II 2008/09/19 AGFA Hong Kong Limited 2555 9421 SN080982 AGFA IMPAX 4.1 and WEB1000 Versions 3.1 FDA Z-1243-2008 to Z-1244-2008 Class II 2008/09/19 AGFA Hong Kong Limited 2555 9421 FDA Z-1893-2008 to Z-1894-2008 Class II 2008/09/19 Baxter Healthcare Ltd 2807 8500 FDA Z-1588-2008 to Z-1589-2008 Class II 2008/09/19 Bio-Rad Pacific Ltd. 2789 3300 SN080983 SN080984 Baxter Healthcare (Edwards Lifesciences LLC) Fem-Flex II Femoral Venous Cannula and Fem-Flex II Duraflo Treated Femoral Venous Catheter Bio-Rad VARIANT β-thalassemia Short Program Hemoglobin Testing System(Model 270-0019 and 270-0002) SN080985 Allez Spine Laguna Pedicle Screw System (IT-FN1001 and ITFN1007) FDA Z-1819-2008 to Z-1820-2008 Class II 2008/09/19 N/A N/A SN080986 Galil Medical Warming Catheter FDA Z-1698-2008 Class II 2008/09/19 N/A N/A FDA Z-1823-2008 to Z-1824-2008 Class II 2008/09/19 N/A N/A BD Asia Ltd (Hong Kong) N/A Firm Initiated Field Action 2008/09/22 BD Asia Ltd (Hong Kong) 2575 8668 FDA Z-1827-2008 Class II 2008/09/22 N/A N/A FDA Z-1800-2008 to Z-1807-2008 Class II 2008/09/22 N/A N/A FDA Z-1790-2008 to Z-1799-2008 Class II 2008/09/22 N/A N/A SN080987 SN080988 Resonance Technology Headset Model no RTC-2K and RTC-551070 BD Vacutainer 16 x 100 MM Serum Blood Collection tubes, BD Vacutainer 16 x 100 mm SSTII Advance Blood Collection tubes, BD Vacutainer 16 x 100 Glass Calcium Chloride Blood Collection tubes (FA 08002) SN080989 MIM 4.0 and MIM 4.1 SN080990 SN080992 Merit Medical Systems Fluid Administration Set, Custom Kit Mentor Psi-Tec Tubing, Autofuse Tubing, i-Vac Tubing, Lamis Tubing Set, Y Tubing Set, Irrigation Tubing, Psi-Tec SYRINGE Pump Infiltration Tubing, Contour Genesis Infiltration Tubing, Contour Geneses Inf/IR Tubing AND Contour Genesis Aspiration Tubing Encore Medical Keramos Replacement Polyethlene Liner FDA Z-1785-2008 Class II 2008/09/22 N/A N/A SN080993 Orthodocs Cocoon MHRA 2008/006/006/401/006 FSCA 2008/09/24 N/A N/A SN080994 Pride Mobility Quantum Vibe Power Chair MHRA 2008/005/014/301/003 FSCA 2008/09/24 N/A N/A SN080995 MHRA 2008/009/011/061/008 FSCA 2008/09/24 Philips Healthcare - Great China 2821 5480 MHRA 2008/009/011/601/601/002 FSCA 2008/09/24 Beckman Coulter Hong Kong Ltd 2240 6150 SN080997 Philips BV Pulsera and Endura, C-arm Beckman Coulter Access Immunoassay Systems HAV Ab Reagent Kit Tyco Healthcare Hot/Cold Pack TGA N/A N/A 2008/09/24 COVIDIEN 3157 7220 SN080998 Various Hot/Cold Gel Pack TGA N/A N/A 2008/09/25 N/A N/A SN080999 GE 1.5T and 3.0T Sigma HDx System and GE Signa Excite 1.5T MR and 3.0T MR System FDA Z-1890-2008 to Z-1891-2008 Class II 2008/09/26 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081000 Philips Gallileo Automatic Collimator (Part Number 9896 010 00612, 9896 010 00614, 9896 010 00615) FDA Z-1886-2008 Class II 2008/09/26 Philips Healthcare - Great China 2821 5480 FDA Z-1374-2008 Class II 2008/09/26 Philips Healthcare - Great China 2821 5480 FDA Z-1542-2008 Class II 2008/09/26 N/A N/A SN081003 Philips OmniDiagnost Eleva X-Ray System Hitachi Altaire MRI System Emergency Rundown Switch Unit (ERDU) Stryker OmniFit X-Ray Templates and OmniFit HFx Sell Sheets FDA Z-2054-2008 to Z-2055-2008 Class II 2008/09/26 Stryker China Ltd 2518 6988 SN081004 Stryker Triathlon Femoral Sizer FDA Z-1864-2008 Class II 2008/09/26 Stryker China Ltd 2518 6988 SN081005 Stryker Short Barrel Sideplate (Catalog no. 3362-0-404) FDA Z-2865-2008 Class II 2008/09/26 Stryker China Ltd 2518 6988 SN081006 Stryker Ureteral Kit (Model no.: 220-180-516) and Stryker Ureteral Universal Kit (Model no.: 220-180-517) FDA Z-1866-2008 to Z-1867-2008 Class II 2008/09/26 Stryker China Ltd 2518 6988 SN080991 SN080996 SN081001 SN081002 Medical Device Control Office 25 Department of Health The Government of HKSAR SN081007 Zimmer 4.5 Compression plate-broad (REF 4945-10-01) FDA Z-2179-2008 Class II 2008/09/26 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN081008 Medtronic Physio-Control Internal Defibrillator Handles and Internal Defibrillation Electrodes FDA Z-2035-2008 to Z-2036-2008 Class II 2008/09/26 Medtronic International, Ltd. 2907 5911 SN081009 Medtronic VNUS Medical U-CLIP Remocal Tool (UREM 1860) FDA Z-1609-2008 Class II 2008/09/26 Medtronic International, Ltd. 2907 5911 SN081010 Johnson and Johnson Depuy LCS Knee FDA Z-1812-2008 Class II 2008/09/26 Johnson & Johnson Medical (HK) 2738 6027 SN081011 Merit Fountain Indusion System, 4F (REF IS4-90-50) FDA Z-2107-2008 Class II 2008/09/26 N/A N/A SN081012 I-Flow On-Q C-bloc 400ml (REF CB005) FDA Z-2133-2008 Class II 2008/09/26 N/A N/A SN081013 I-Flow ON-Q PainBuster Infusion Pump (REF PS6504, Part No. 5001260) FDA Z-1869-2008 Class II 2008/09/26 N/A N/A SN081014 Intuitive Surgical da Vinvi S Surgical System (Model no IS2000) FDA Z-2204-2008 Class II 2008/09/26 N/A N/A SN081015 Intuitive Surgical DA Vinci Surgical System Model S Cardiac Probe Gasper Instrument (Model IS2000) FDA Z-1811-2008 Class II 2008/09/26 N/A N/A SN081016 Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery System, M-Style Cup with UVR and Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System FDA Z-1887-2008 to Z-1889-2008 Class II 2008/09/26 N/A N/A SN081017 Integra LifeSciences PANTA Nails FDA Z-1877-2008 Class II 2008/09/26 N/A N/A SN081018 Accuracy Cyberknife Robotic Radiosurgery System FDA Z-1862-2008 Class II 2008/09/26 Accuray Asia Ltd 2247 8628 FDA Z-1659-2008 to Z-1660-2008 Class II 2008/09/26 N/A N/A SN081019 SN081020 GMP LS-232 Large 12 LeadWear Single Pack and LS-202 Large LeadWear Combo Pack Diamedix Is-anti-Gliadin IgG Enzyme Immunoassay Test kit (Catalog no 720-800) FDA Z-1684-2008 Class II 2008/09/26 N/A N/A SN081021 Cardiac Science Electrode Adaptor Cable Quick-Combo System (Model 9055) FDA Z-1714-2008 Class II 2008/09/26 N/A N/A SN081022 Sun Biomedical VisuaLine Single Dip Oxycodone, VisuaLine Propoxyphene test system, VisuaLine Tricyclic Antidepressants FDA Z-1873-2008 to Z-1875-2008 Class II 2008/09/26 N/A N/A Greiner Bio-One Vacuette, Plastic Cannula HOLDEX (Ref 450216) FDA Z-2134-2008 Class II 2008/09/26 Mekim Ltd 2774 8300 FDA Z-2205-2008 to Z-2208-2008 Class II 2008/09/26 N/A N/A Health Canada 43308 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081023 SN081024 SN081025 ICU Medical Hospira Intralock Lipid Compatible 3-Way Stopcock, Hospira Monitoring Kit (PA Line) and Left Heart Kit Philips Brilliance CT Big Bore System-Main Unit and Brilliance CT System (16P) SN081026 Philips Diagnost 94, Diagnost 96 and Diagnost 97 Health Canada 43340 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081027 Philips Brilliance 64 Slice CT System-Main Unit Health Canada 43322 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081028 Philips Essenta DR Health Canada 43360 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081029 Philips Isite Pacs Health Canada 43324 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081030 Philips HDI 4000 System Health Canada 43395 Type II 2008/09/29 Philips Healthcare - Great China 2821 5480 SN081031 Siemens Angiostar; Multistar D, P; Bicor HS, HS-ACS; Coroskop HS, HS-ACS, HI-P, C and Neurostar Top Health Canada 43314 Type II 2008/09/29 Siemens Ltd. 2810 7533 SN081032 Siemens Axiom Luminos TF Health Canada 43288 Type II 2008/09/29 Siemens Ltd. 2810 7533 SN081033 GE Instatrak 3500 System Health Canada 42398 Type II 2008/09/29 GE Medical Systems Hong Kong Ltd. 2783 1838 SN081034 Impac Medical Systems Sequencer (Model 40000-000000-RO) Health Canada 43446 Type II 2008/09/29 N/A N/A SN081035 Zimmer Patient Helper Reinforced Overhead Bar Health Canada 43273 Type II 2008/09/29 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN081036 Porex Surgical Ocular Conformers (Non-Vented and Vented) Health Canada 43459 Type II 2008/09/29 N/A N/A Medical Device Control Office 26 Department of Health The Government of HKSAR SN081037 Medilab Beautytek Premium Edition Health Canada 41783 Type II 2008/09/29 N/A N/A SN081038 Home Telehealth WebVMC Remote Nurse MHRA 2008/008/018/061/010 FSCA 2008/09/29 N/A N/A SN081039 Covidien Argyle Suction Catheter MHRA 2008/007/029/061/011 FSCA 2008/09/29 Covidien 2574 3251 SN081040 Bauerfeind AG Shin Tubes Mod. A3-Ti200/400 and A3-St200 MHRA 2007/009/018/401/005 FSCA 2008/09/29 N/A N/A SN081041 B Braun Microspeed Uni Mobile stand GA411 MHRA 2008/009/022/061/003 FSCA 2008/09/29 B Braun Medical Hong Kong N/A N/A SN081042 Coloplast Folysil Xtra Silicone Indwelling Catheters MHRA 2008/008/028/401/010 FSCA 2008/09/29 Coloplast (Hong Kong) Ltd SN081043 Utah Intran Plus IUPC trays MHRA 2008/009/016/051/001 FSCA 2008/09/30 N/A N/A SN081044 Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 MHRA 2008/006/005/291/004 FSCA 2008/09/30 Siemens Ltd 2810 7533 SN081045 Draeger Sub-Acute Care Ventilator Carina MHRA 2008/007/003/401/011 FSCA 2008/09/30 N/A N/A SN081046 BD Visitec High Viscosity Injector MHRA 2008/009/022/061/010 FSCA 2008/09/30 BD Asia Ltd (Hong Kong) 2722 5660 SN081047 Johnson and Johnson Animas™ 2020 and IR 1200 Insulin Pump MHRA 2008/009/022/061/015 FSCA 2008/09/30 Johnson & Johnson Medical (HK) 2738 6027 SN081048 Sybron Endo K3 Engine File G-Pack Health Canada 43337 Type II 2008/09/30 N/A N/A SN081049 Adac Laboratories Precedence System (6 and 16 Slice) Health Canada 43306 Type II 2008/09/30 N/A N/A SN081050 Apogee Intermittent Catheter Health Canada 43335 Type II 2008/09/30 N/A N/A SN081051 Medacta AMIS Universal Table for Leg Positioner (Model no. 01.15.10.0172) FDA Z-1870-2008 Class II 2008/09/30 N/A N/A SN081052 EBI Trauma Fixation Systems FDA Z-2012-2008 Class II 2008/09/30 N/A N/A SN081053 Biomet Hybrid Glenoid Boss Cutter; item 406150 FDA Z-1658-2008 Class II 2008/09/30 N/A N/A SN081054 Biomet OSS Interlok IM Stem Z-1879-2008 to Z-1881-2008 N/A N/A Boston Scientific Precision Charger 1.0 (UPN M365SC53000) Class II Firm Initiated Field Action 2008/09/30 SN081055 FDA Boston Scientific Hong Kong Ltd 2008/09/30 Boston Scientific HK Limited 2960 7136 Medical Device Control Office N/A 27 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - August 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDA/2008/059 MDA Date of Issue (YYYY/MM/DD) 2008/08/01 MHRA 2008/002/026/401/001 FSCA 2008/08/01 N/A N/A Stryker Scorpio Series 7000 Tibial Impactor/Extractor MHRA 2008/007/007/061/017 FSCA 2008/08/01 Stryker China Ltd 2518 6915 ThermoFisher Scientific BO0348V Maximum recovery diluent MHRA 2008/007/018/601/501 FSCA 2008/08/01 N/A N/A Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/08/04 Baxter Healthcare Ltd 2807 8500 2008/08/05 N/A N/A MDCO Ref. Description of Product No. SN080801 Bayer Ascensia Contour blood glucose meters SN080802 Levitronix CentriMag Systems SN080803 SN080804 Source of Information* MHRA Reference No. by Source Alert Type by Source Local Agent Bayer Healthcare Agent Contact Telephone No 2814 4836 SN080805 Baxter FLOSEAL Endoscopic Applicator (#1500181) SN080806 Arjo Carendo multi-purpose hygiene chair MHRA MDA/2008/060 MDA SN080807 CASMED 740 Series Multiparameter Monitor MHRA 2008/007/022/061/001 FSCA 2008/08/05 N/A N/A SN080808 Siemens ADVIA Centaur CP immunoassay system MHRA MDA/2008/061 MDA 2008/08/05 N/A N/A SN080809 TomoTherapyR Hi-Art Treatment System MHRA 2008/004/024/061/020 FSCA 2008/08/05 N/A N/A SN080810 TomoTherapyR Hi-Art Treatment System MHRA 2008/004/024/061/021 FSCA 2008/08/05 N/A N/A SN080811 GE Healthcare Centricity Perinatal (formerly QS) System - PFILS software FDA Z-2037-2008 Class II 2008/08/07 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080812 GE Healthcare Precision 500D Classical R&F System with control room PC (Model no. 5117866-27) FDA Z-0274-2008 Class II 2008/08/07 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080813 Intuitive Surgical Da Vinci S 8mm Instrument Cannula (Model IS2000, Part No. 400254-01, 400255-01) FDA Z-1348-2008 Class II 2008/08/07 N/A N/A SN080814 Synovis GEM 2753 Microvascular Anastomotic Coupler, 2.5mm (REF GEM2753/1, P/N 5111-00250-010) FDA Z-2138-2008 Class II 2008/08/07 N/A N/A SN080815 Varian Acuity with Conebeam COMPUTED Tomography (Model No. H77) FDA Z-1460-2008 Class II 2008/08/07 Varian Medical Systems Pacific Inc. 2724 2836 SN080816 Varian High-Definition 120 MultiLeaf Collimator (Product code: H56) FDA Z-1459-2008 Class II 2008/08/07 Varian Medical Systems Pacific Inc. 2724 2836 SN080817 Philips 1.5T Intera and 1.5T Achieva systems MHRA 2008/007/022/051/005 FSCA 2008/08/08 Philips Medical System 2876 7525 SN080818 Biomet Pectus Table Top Bender (part # 01-3906) MHRA 2008/001/018/291/026 FSCA 2008/08/11 N/A N/A 2738 2818 N/A SN080819 Johnson and Johnson Depu Delta XTEND MHRA 2008/007/023/061/004 FSCA 2008/08/11 Johnson & Johnson Medical Hong Kong SN080820 Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric Infusion Pumps MHRA 2008/007/022/051/006 FSCA 2008/08/13 N/A SN080821 Stille Sonesta 6210 fluoroscopy procedure table MHRA MDA/2008/063 MDA 2008/08/13 N/A N/A SN080822 ThermoFisher EB0212E Cooked meat medium MHRA 2008/007/021/601/503 FSCA 2008/08/13 N/A N/A SN080823 Regulatory Insight Rolling Walkers (Rollators) Health Canada 42905 Type II 2008/08/13 N/A N/A SN080824 Maquet Servo-I (Model 640870800 E407E) Health Canada 43009 Type II 2008/08/13 Maquet Hong Kong Ltd 2393 9511 Medical Device Control Office 28 Department of Health The Government of HKSAR SN080825 Teleflex Medical A) Dermahook Neuro Elastic Retractors 1/2", B) Dermahook Neuro Elastic Retractors 1/4" Health Canada 42249 Type II 2008/08/13 N/A N/A SN080826 Hologic A) Delphi Bone Densitometer, B) Discovery QDR Bone Denositometer, C) Explorer QDR Bone Densitometer, D) QDR 4500 Bone Densitometer Health Canada 43205 Type II 2008/08/13 N/A N/A SN080827 Acist Angiographic System - Table Kit Health Canada 43028 Type II 2008/08/13 Pacific Medical (Hong Kong) Ltd. 2343 8009 SN080828 Brainlab AG Brainscan Treatment Planning Software Health Canada 42381 Type II 2008/08/13 N/A N/A SN080829 Philips A) PCR AC-500/PCR-5000, B) PCR Corado Eleva, C)PCR Compano System / PCR Eleva S Plus Health Canada 43176 Type II 2008/08/13 Philips Medical System 2876 7525 SN080830 Philips Digital Diagnost Health Canada 43190 Type II 2008/08/13 Philips Medical System 2876 7525 SN080831 Draeger Fabius Titro Anesthesia System Health Canada 43160 Type II 2008/08/13 Draeger Medical Hong Kong Ltd. 2877 3077 SN080832 Hospira LifeCare PCA Label Utilility, Version 1.0 CD FDA Z-1181-2008 Class II 2008/08/14 Hospira Ltd 2285 8382 SN080833 Beckman Coulter Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager (Part no 626553 and 6605628) FDA Z-1529-2008 Class II 2008/08/14 Beckman Coulter Hong Kong Ltd 2240 6150 SN080834 3M Comply EO Chemical indicators Strips (Catalog # 1251) FDA Z-1568-2008 Class II 2008/08/14 3M Hong Kong Ltd 2806 6314 SN080835 Johnson and Johnson Medical Advanced Sterilization Products EvoTech Endoscope Cleaner & Reprocessor (Product Code 50004 AND 50004-002) FDA Z-1368-2008 to Z-1369-2008 Class II 2008/08/14 Johnson & Johnson Medical Hong Kong 2738 2818 SN080836 Siemens IMMULITE / IMMULITE 1000 Progesterone MHRA 2008/007/025/061/020 FSCA 2008/08/14 Siemens Ltd. 2810 7533 SN080837 Homecraft Rolyan Savanah Raised Toilet Seat Brackets MHRA 2008/003/006/401/011 FSCA 2008/08/14 N/A N/A SN080838 Stryker REDUCTION SPOON 09MM MHRA 2008/007/023/061/010 FSCA 2008/08/14 Stryker China Ltd 2518 6915 SN080839 Activate Patron Bohemia Strollers MHRA 2006/010/011/081/003 FSCA 2008/08/14 N/A N/A SN080840 Sunrise Medical Lomax Kid Active Recliner Attendant Push Wheelchairs MHRA 2008/001/003/061/022 FSCA 2008/08/15 N/A N/A 2008/08/15 N/A N/A 2008/08/15 Varian Medical Systems Pacific Inc. 2722 8123 SN080841 Apline Microtargeting Electrode Cable Apline BioMed N/A Varian Medical Systems Pacific Inc. N/A Firm Initiated Field Action Firm Initiated Field Action SN080842 Varian Exact Couch Pinch Point SN080843 GE Healthcare Solar 8000/i/M MHRA 2008/007/024/601/510 FSCA 2008/08/18 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080844 Ortho Europe Uniaxial Foot MHRA 2008/002/026/061/008 FSCA 2008/08/18 N/A N/A SN080845 Philips MRI Magnet Venting System Inspection MHRA 2008/007/023/061/006 FSCA 2008/08/18 Philips Medical System 2876 7525 SN080846 ConMed Frazier and Poole Suction Instruments MHRA 2008/007/015/061/018 FSCA 2008/08/18 N/A N/A SN080847 Medi-Plinth Three function electric foot switches MHRA 2008/005/008/401/005 FSCA 2008/08/18 N/A N/A SN080848 Siemens Magnetom Mobile Systems MHRA 2008/007/031/061/014 FSCA 2008/08/19 Siemens Ltd. 2810 7533 SN080849 KCI 500 ml Canister for Infovac MHRA 2008/007/031/061/003 FSCA 2008/08/19 N/A N/A SN080850 Lomax Mobility Wheelchairs MHRA 2006/007/019/081/009 FSCA 2008/08/19 N/A N/A SN080851 Medtronic MaximoR II Device MHRA 2008/007/021/401/014 FSCA 2008/08/19 Medtronic International Limited 2919 1300 Medical Device Control Office 29 Department of Health The Government of HKSAR SN080852 Roche Diagnostics modular analytics SN080853 Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute Renal Therapy SN080854 Chiron PROCLEIX (Assay Reagent) Press SN080855 ArthroCare Topaz XL ArthroWand MHRA SN080856 MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator MHRA SN080857 Smiths Medical CADD-MS 3 Ambulatory Infusion Pimp (Model 7400) SN080858 Philips Medical Systems iSite PACS version 3.6.28.0 and version 4.1.17.0 SN080859 Varian Medical Systems On-Board Imager, versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator SN080860 SN080861 SN080862 BD FACSDiva Software Versions 4.0.1 to 5.0.2 Flow Cytometry Acquistion & Analysis software (Catalog no 641609) BD Difco(tm) Shigella Antiserum Poly Group B (Catalog no. 228351 and 210722) Atrium Medical HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip MHRA 2008/007/011/061/012 FSCA 2008/08/20 Roche Diagnotics (Hong Kong) Ltd. 2485 7510 Health Canada N/A N/A 2008/08/20 Baxter Healthcare Ltd 2807 8500 N/A N/A 2008/08/21 Chiron Limited 2161 3104 2008/008/001/061/001 FSCA 2008/08/21 N/A N/A 2008/008/004/051/010 FSCA 2008/08/21 Medtronic International Limited 2919 1300 FDA Z-1621-2008 Class II 2008/08/21 Goodman Medical Supplies Ltd 2332 4455 FDA Z-1443-2008 to Z-1444-2008 Class II 2008/08/21 Philips Medical Systems 2821 5480 FDA Z-1442-2008 Class II 2008/08/21 Varian Medical Systems Pacific Inc. 2722 8123 FDA Z-1525-2008 Class II 2008/08/21 BD Asia Ltd (Hong Kong) 2722 5660 FDA Z-1527-2008 to Z-1528-2008 Class II 2008/08/21 BD Asia Ltd (Hong Kong) 2722 5660 FDA Z-1830-2008 to Z-1853-2008 Class II 2008/08/21 N/A N/A SN080863 GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) FDA Z-1526-2008 Class II 2008/08/21 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080864 Impac Medical Systems SEQUENCER, MOSAIQ versions 1.3 and 1.4 (Model # 40003-001000-RO) FDA Z-1515-2008 Class II 2008/08/21 N/A N/A SN080865 Medtronic PROSTIVAR RF Model 8929 Hand Piece MHRA 2008/008/006/061/010 FSCA 2008/08/25 Medtronic International Limited 2919 1300 SN080866 BrainlabVectorVision Sky and/or BrainSUITE NET system MHRA 2008/008/004/051/009 FSCA 2008/08/25 BrainLAB Ltd. (Hong Kong) SN080867 Varian Exact Couch with Exact Couch Top MHRA 2008/008/007/061/015 FSCA 2008/08/25 Varian Medical Systems Pacific Inc. 2722 8123 SN080868 Maquet Expiratory Valve Coils MHRA 2008/007/016/061/004 FSCA 2008/08/25 Maquet Hong Kong Ltd 2393 9511 SN080869 GE Healthcare CT/SPECT Studies of Brain Scans MHRA 2008/008/011/051/011 FSCA 2008/08/25 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080870 Altomed Irrigating handpiece A3404 MHRA 2008/008/005/051/002 FSCA 2008/08/25 N/A N/A SN080871 B Braun Prevision Implant System MHRA 2008/008/004/061/010 FSCA 2008/08/25 B Braun Medical Hong Kong N/A SN080872 SN080873 GE Healthcare CT/SPECT Studies of Brain Scans Cook Endoureterotomy Stent Set MHRA MHRA 2008/008/011/051/011 2008/007/021/061/001 FSCA FSCA 2008/08/25 2008/08/25 GE Medical Systems HK Ltd Cook Asia Ltd. 2783 1838 N/A SN080874 Apex TS 1211/1311 Combo Unit Health Canada 41710 Type II 2008/08/27 N/A N/A SN080875 Impac Medical Systems SEQUENCER (Model: 50200-000000-RO) Health Canada 33877 Type I 2008/08/27 N/A N/A SN080876 Dentsply Osteograf N-300 (Model: 930000-304) Health Canada 41213 Type II 2008/08/27 N/A N/A SN080877 Dentsply Lexicon size 15 dental hand files Health Canada 40992 Type II 2008/08/27 N/A N/A SN080878 Synthes Labelling for Synthes Power Drive (Model: 530.1) Health Canada 43294 Type II 2008/08/27 N/A N/A SN080879 BD BBL Staphyoside Test (Model: 240952, 240953) Health Canada 41510 Type II 2008/08/27 BD Asia Ltd (Hong Kong) 2575 8668 SN080880 Tyco Argyle Suction Catheter (Model: 1180-851121, 1180-851147) Health Canada 43260 Type II 2008/08/27 Tyco Healthcare (HKSAR) LTD 2574 3251 SN080881 Philips Allura XPER FD10, Allura XPER FD 20 system, Allura XPER FD 20/10 System, Integris Allura, Integris H5000F Cardiology Imaging System Health Canada 43276 Type II 2008/08/27 Philips Medical System 2876 7525 Medical Device Control Office 30 Department of Health The Government of HKSAR SN080882 Philips Achieva 1.5T MRI System - Sense Torso Coil, Intera 1.5T MRI System - Sense XL Torso Coil Health Canada 43296 Type II 2008/08/27 Philips Medical System 2876 7525 SN080883 Siemens MicroScanR Dried Overnight Gram Negative and Synergies plusR Negative Panels MHRA 2008/008/013/061/009 FSCA 2008/08/27 Siemens Ltd. 2810 7533 SN080884 Johnson and Johnson Vicryl Rapide MHRA 2008/008/011/061/007 FSCA 2008/08/27 Johnson & Johnson Medical (HK) 2738 2818 SN080885 Medtronic Deep Brain Stimulator lead kit with cap MHRA 2008/008/015/061/004 FSCA 2008/08/27 Medtronic International Limited 2919 1300 SN080886 Molnlycke ProcedurePak MHRA 2008/007/023/061/008 FSCA 2008/08/27 N/A N/A SN080887 Beckman Coulter Access Power Supply Assembly Seld (Part No.: A48196/6845C) FDA Z-1183-2008 Class II 2008/08/28 Beckman Coulter Hong Kong Ltd 2240 6150 FDA Z-1513-2008 to Z-1514-2008 Class II 2008/08/28 Boston Scientific HK Limited 2960 7136 FDA Z-2139-2008 Class II 2008/08/28 Abbott Laboratories Ltd. 2806 4021 FDA Z-1694-2008 Class II 2008/08/28 Covidien 2574 3251 SN080888 SN080889 SN080890 Boston Scientific VITALITY DR+ ICD (model 1872) and VITALITY EL (models T127, T167, T177) ICD Abbott CELL-DYN Sapphire Hematology Analyzer (List No. 08H0001) Mallinckrodt OptiVantage DH Injection System (Catalog# V8400, Part no. 241078 & Catalog# V8402, Part # 241079) SN080891 Stryker Omnifit EON Surgical Protocol FDA Z-1750-2008 Class II 2008/08/28 Stryker China Ltd 2518 6988 SN080892 Stryker Radius Rod Persuader and Radius Capsin (Catalog # 486619190, 486619210) FDA Z-1377-2008 to Z-1378-2008 Class II 2008/08/28 Stryker China Ltd 2518 6988 SN080893 Siemens Medical charged-particle radiation therapy system FDA Z-1769-2008 Class II 2008/08/28 Siemens Ltd. 2810 7533 SN080894 Biomet Modular Microplasty Cup Inserter and Impactor FDA Z-1185-2008 to Z-1187-2008 Class II 2008/08/28 N/A N/A SN080895 Bio-Rad MONOLISA Anti-HBc EIA (Catalog no 26186) FDA Z-1189-2008 Class II 2008/08/28 Bio-Rad Pacific Ltd. 2789 3300 SN080896 GIVEN Diagnostic System with PillCam SB Capsule FDA Z-1447-2008 Class II 2008/08/28 N/A N/A SN080897 AMO Excimer Laser System FDA Z-1695-2008 Class II 2008/08/28 AMO Asia Limited 2480 3330 FDA Z-1770-2008 to Z-1772-2008 Class II 2008/08/28 N/A N/A Class II 2008/08/28 N/A N/A SN080898 Medline Bariatric Wheelchair SN080899 EKOS EndoWave Infusion System FDA Z-1773-2008 SN080900 Acumed Osteo-Clage Cable System Package Assembly (01-0001-S) FDA Z-2140-2008 Class II 2008/08/28 N/A N/A SN080901 StatSampler 200 uL, Li Heparin (Ref: SS2H) FDA Z-2234-2008 Class II 2008/08/28 N/A N/A SN080902 Philips HeartStart MRx Monitor/Defibrillator MHRA 2008/008/018/061/026 FSCA 2008/08/28 Philips Medical System 2876 7525 SN080903 Smith & Nephew Dyonics 25 Tubeset kits MHRA 2008/008/015/061/007 FSCA 2008/08/28 N/A N/A SN080904 Siemens Trugene HIV-1 Module for GuideLines Rules 11.0, 12.0 & 13.0 MHRA 2008/008/018/061/021 FSCA 2008/08/28 Siemens Limited 2810 7533 SN080905 Sorin D901 Lilliput 1/ D100 Dideco Kids MHRA 2008/008/020/061/006 FSCA 2008/08/28 N/A N/A SN080906 Medtronic Disposable Magellan Kits and One Source Kits MHRA 2008/008/021/061/010 FSCA 2008/08/28 Medtronic International Limited 2919 1300 SN080907 Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal Dialysis System MHRA 2008/005/028/061/023 FSCA 2008/08/29 Baxter Healthcare Ltd 2807 8500 SN080908 Leckey Squiggles Stander on Pivot Chassis MHRA 2008/005/008/401/003 FSCA 2008/08/29 N/A N/A SN080909 Philips Allura Xper FD10 and FD10/10 MHRA 2008/007/002/061/011 FSCA 2008/08/29 Philips Medical System 2876 7525 SN080910 GE Voluson E8 Ultrasound Systems MHRA 2008/005/019/601/350 FSCA 2008/08/29 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080911 BrainlabExac TRac Infrared Tracking Platform 5.0, 5.5 MHRA 2008/008/011/061/001 FSCA 2008/08/29 BrainLAB Ltd. (Hong Kong) N/A SN080912 Baylis Medical Toronto Transseptal Catheter Model TSC-50-75 MHRA 2008/008/021/061/001 FSCA 2008/08/29 N/A N/A Medical Device Control Office 31 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - July 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDA/2008/044 MDA Date of Issue (YYYY/MM/DD) 2008/07/02 N/A Agent Contact Telephone No N/A MHRA 2008/006/002/601/380 FSCA 2008/07/02 Abbott Laboratories Ltd. 2806 4021 Anspach Sterile Single-use Cuting Burrs MHRA 2008/006/011/291/004 FSCA 2008/07/02 N/A N/A Arrow International Cannon catheter , Cannon catheter II and Edge catheter MHRA 2008/006/018/061/010 FSCA 2008/07/02 N/A N/A MDCO Ref. Description of Product No. SN080701 Invacare Action³ manual wheelchair SN080702 Abbott Diagnostics ARCHITECT c8000 System SN080703 SN080704 Source of Information* MHRA Reference No. by Source Alert Type by Source Local Agent SN080705 TerumoTubing packs for extracorporeal circulation of blood MHRA 2008/005/021/401/005 FSCA 2008/07/02 TERUMO CHINA (H.K.) LTD. 2866 0811 SN080706 BioMerieux Agars 43001, 43041, and 43401 MHRA 2008/006/018/601/425 FSCA 2008/07/02 Biomerieux China Ltd (HK) N/A SN080707 Handicare B.V. Beatle / Puma power wheelchairs MHRA 2008/001/007/301/001 FSCA 2008/07/02 N/A N/A SN080708 Biomet UK Lactosorb L Template MHRA 2008/005/021/061/017 FSCA 2008/07/02 N/A N/A SN080709 Stryker Reflex Revision Screwdriver MHRA 2008/006/012/291/005 FSCA 2008/07/02 Stryker China Ltd 2518 6915 SN080710 BioLytical Laboratories INSTI HIV-1 /HIV-2 antibody test MHRA 2008/006/011/401/013 FSCA 2008/07/02 N/A N/A SN080711 Sunrise Medical Groove Power Wheelchairs MHRA 2008/003/003/261/001 FSCA 2008/07/03 N/A N/A SN080712 Medtronic Sutureless Connector Intrathecal Catheters MHRA 2008/006/025/061/013 FSCA 2008/07/03 Medtronic International, Ltd. 2919 1300 SN080713 Remploy Access & Accent wheelchair MHRA 2007/010/023/261/001 FSCA 2008/07/03 N/A N/A SN080714 Beckman Coulter Access Ultra sensitive Insulin Assay Kit (Part Number 33410) FDA Z-1160-2008 Class II 2008/07/03 Beckman Coulter Hong Kong Ltd 2240 6150 SN080715 Stryker Solar HA Humeral Stem with Plasma Coating 7mm to 17mm FDA Z-1236-2008 Class II 2008/07/03 Stryker China Ltd 2518 6915 SN080716 AGFA HeartLabCardiovascular DICOMstore (Model # L9M8E) FDA Z-1241-2008 Class II 2008/07/03 AGFA Hong Kong Limited 2555 9421 SN080717 AGFA HeartLab Cardiovascular Results Management Product (Model No.: L58RZ and L9MWQ) FDA Z-1242-2008 Class II 2008/07/03 AGFA Hong Kong Limited 2555 9421 SN080718 AGFA IMPAX 6.2.1 Network Gateway Server, License Key (Catalog # ABC) FDA Z-1306-2008 Class II 2008/07/03 AGFA Hong Kong Limited 2555 9421 Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/07/03 Boston Scientific Hong Kong Ltd 2960 7136 SN080719 Boston Scientific Lumenis/Slimline Fiber Strippers SN080720 Kentec Medical Reusable Ohmeda Compatible Finger Clip Sensor (Model Number: E403-02, Product code: PS2225) FDA Z-1188-2008 Class II 2008/07/03 N/A N/A SN080721 Medline IL Latex-Free Breathing Bags,; Reservoir Bags FDA Z-1162-2008 to Z-1164-2008 Class II 2008/07/03 N/A N/A SN080722 Huntleigh Healthcare BabyCare crib trolleys MHRA MDA/2008/048 MDA 2008/07/03 N/A N/A SN080723 Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe MHRA MDA/2008/049 MDA 2008/07/03 Goodman Medical Supplies Ltd 2332 4455 N/A Firm Initiated Field Action 2008/07/07 Alcon Hong Kong Ltd 2161 0844 2008/001/010/401/007 FSCA 2008/07/07 N/A N/A 2008/006/025/181/011 FSCA 2008/07/07 Draeger Medical Hong Kong Ltd. 2877 3077 SN080724 SN080725 SN080726 Alcon MONARCH II IOL Delivery System - Cartridge Model B ( Pat # Alcon Hong Kong Ltd 8065977758; Lot#: 174244, 174250) Park House Healthcare PHP 198, PHP396, PHP398 & PHP399 MHRA Pumps Draeger Medical Intensive Care ventilators Medical Device Control Office MHRA 32 Department of Health The Government of HKSAR SN080728 TherapostureTheracare Beds supplied with Mesh Linked Padded Rails Medtronic SynchroMed® II Implantable Infusion Pump SN080729 Liko AB Universal SlingBar SN080730 Invacare Harrier Heavy Duty (HD) battery powered wheelchair SN080731 Quest 88 Kaye Posture Control Walkers MHRA 2007/011/015/401/003 FSCA 2008/07/08 N/A SN080732 Steris Quick Connect (Model QXCXXXX) Health Canada 38366 Type II 2008/07/10 Swedish Trading Co., Ltd N/A Type II 2008/07/10 Cardinal Health N/A SN080727 MHRA 2007/009/027/401/001 FSCA 2008/07/07 N/A N/A MHRA 2008/005/029/291/001 FSCA 2008/07/07 Medtronic International, Ltd. 2919 1300 MHRA 2008/006/024/071/002 FSCA 2008/07/07 N/A N/A MHRA MDA/2008/050 MDA 2008/07/08 N/A N/A N/A Health Canada 39224 SN080734 Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack, C) Sterile Cardiovascular Universal Siemens Oncor Expression (Model 7360717, 8139839) Health Canada 39313 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080735 Siemens AG Somatom Definition (Model 7741445) Health Canada 39782 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080736 GE Healthcare Precision RX/I Remote Imaging System (Model 5117828) Health Canada 40889 Type II 2008/07/10 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080737 Trinity Biotech D-Dimer High Control Health Canada 41341 Type II 2008/07/10 N/A N/A 2738 2818 SN080733 SN080738 Cordis Smart Control Nitinol Stent System (Model C10040SL) Health Canada 41441 Type II 2008/07/10 Johnson & Johnson Medical Hong Kong SN080739 Siemens AG Magicview 300 (Model VA60A) Health Canada 41521 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080740 Siemens Mevasim-S, Simview 3000, Simview NT Health Canada 41532 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080741 Siemens Dimension Automated LDL Calibrator (Model DC131) Health Canada 41796 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080742 Walter Lorenz Surgical 4MM Stella Osteotomes (Model 01-0575), 6MM Stella Osteotomes (Model 01-0576) Health Canada 42037 Type II 2008/07/10 Swedish Trading Co., Ltd N/A SN080743 Nonin Model PalmSAT handheld pluse Oximeter Health Canada 42163 Type II 2008/07/10 At-Home Healthcare Company Ltd N/A Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 SN080744 Philips Collimators 989601000612, 989601000614, 989601000615 Health Canada 42275 Type II 2008/07/10 SN080745 Siemens Advia 120, 2120, Health Canada 42277 Type II 2008/07/10 Siemens Ltd. 2810 7533 SN080746 Roche Myoglobin Control Set Health Canada 42325 Type II 2008/07/10 Roche Diagnotics (Hong Kong) Ltd. 2485 7510 SN080747 AGFA Drystar AXYS Health Canada 42393 Type II 2008/07/10 AGFA Hong Kong Limited 2555 9421 SN080748 Elekta Precise Treatment Table Health Canada 42401 Type II 2008/07/10 Elekta Ltd N/A SN080749 Computerized Medical Systems Monaco Health Canada 42691 Type II 2008/07/10 N/A N/A SN080750 Edwards LifeStent FlexStar Biliary Stent System FDA Z-1246-2008 to Z-1296-2008 Class II 2008/07/10 N/A N/A SN080751 AGFA Impax 4.5, 5.1, 5.2 ans 5.2x Picture Archiving System (PACs) FDA Z-1307-2008 Class II 2008/07/10 AGFA Hong Kong Limited 2555 9421 SN080752 Stryker Peek Electrosurgical Handle Health Canada 34279 Type II 2008/07/11 Stryker China Ltd 2518 6915 SN080753 GE OEC Medical Systems Aspirators (Model 1006236-001) Health Canada 36242 Type II 2008/07/11 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080754 Siemens Coherence Oncologist (Model 7351898) Health Canada 42716 Type II 2008/07/11 Siemens Ltd. 2810 7533 SN080755 Balder Battery powered wheelchairs MHRA 2008/004/003/301/001 FSCA 2008/07/11 N/A N/A SN080756 Siemens Mevatron Primus, Mevatron MX-2, Oncor Expression, Oncor Impression IMRT Plus Health Canada 42781 Type II 2008/07/11 Siemens Ltd. 2810 7533 SN080757 Lomax Mobility Kid Active Folding Frame with Swing Away Footrests MHRA 2007/012/006/061/004 FSCA 2008/07/14 N/A N/A Medical Device Control Office 33 Department of Health The Government of HKSAR SN080758 Electric Mobility Scooters MHRA 2007/008/002/301/003 FSCA 2008/07/14 N/A N/A SN080759 Q'Straint Wheelchair tie-downs MHRA 2008/004/003/301/003 FSCA 2008/07/14 N/A N/A SN080760 Edwards Lifesciences Fogarty Fortis™ Catheter MHRA 2008/006/030/061/018 FSCA 2008/07/14 N/A N/A SN080761 Philips Medical Systems Allura Xper and Integris Systems MHRA 2008/007/001/061/020 FSCA 2008/07/14 PHAROS INTERNATIONAL LTD. N/A SN080762 Becton Dickinson BD™ Saline Syringers MHRA 2008/006/030/061/002 FSCA 2008/07/14 BD Asia Ltd (Hong Kong) 2722 5660 SN080763 Gyrus ACMI Dual Lumen Catheter MHRA 2008/006/027/601/455 FSCA 2008/07/14 N/A N/A SN080764 GE Healthcare vascular systems MHRA 2008/007/001/061/014 FSCA 2008/07/14 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080765 Sorin Biomedica Cardio Freedom Solo Biological Heart Valve MHRA 2008/007/009/061/010 FSCA 2008/07/14 N/A N/A SN080766 Zimmer NexGen® Complete Knee Solution MHRA 2008/007/002/061/012 FSCA 2008/07/14 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 Boston Scientific HK Ltd SN080767 Boston Scientific Platinum PlusT Cononary Guidwire MHRA 2008/007/001/061/022 FSCA 2008/07/14 SN080768 Dade Behring StratusR CS Acute Care? Troponin I TestPaks MHRA 2008/007/002/061/014 FSCA 2008/07/16 Siemens Ltd. 2810 7533 SN080769 Abbott ARCHITECT Total β-HCG calibrator MHRA 2008/006/015/601/416 FSCA 2008/07/16 Abbott Laboratories Ltd. 2806 4021 SN080770 ArthroCare Covator Arthro Wand MHRA 2008/004/016/401/009 FSCA 2008/07/16 N/A N/A 2821 5480 SN080771 Philips Medical Systems Biopsy Guide Starter Kits SN080772 BD Vacutainer Blood Collection Tubes Containing Heparin SN080773 Respironics PLV100 Ventilator (#RCA200802) MHRA 2008/007/003/061/008 FSCA 2008/07/17 Philips Medical Systems Regional Office (Asia Pacific) BD N/A Firm Initiated Field Action 2008/07/21 BD Asia Ltd (Hong Kong) 2722 5660 CELKI Medical Company N/A Firm Initiated Field Action 2008/07/21 CELKI Medical Company 2268 9258 SN080774 Kimal safety fistula needle MHRA MDA/2008/051 MDA 2008/07/22 N/A N/A SN080775 SN080776 Handicare Puma and Beatle battery powered wheelchairs Nucletron SPOT Pro v3.0 MHRA MHRA MDA/2008/052 2008/007/003/061/009 MDA FSCA 2008/07/22 2008/07/22 N/A N/A N/A N/A SN080777 Unomedical OP suction tubing MHRA MDA/2008/053 MDA 2008/07/24 N/A N/A SN080778 Smiths Medical Portex™ Blue Line Ultra tracheostomy kits MHRA MDA/2008/054 MDA 2008/07/24 N/A N/A SN080779 Philips Healthcare HeartStart OnSite automated external defibrillators (AEDs) MHRA 2008/007/003/061/012 FSCA 2008/07/24 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 SN080780 Dade Behring ADVIA Chemistry Systems MHRA 2008/007/002/061/013 FSCA 2008/07/24 Siemens Ltd. 2810 7533 SN080781 Abbott Molecular m2000sp Instrument MHRA 2008/007/003/601/464 FSCA 2008/07/24 Abbott Laboratories Ltd. 2806 4021 SN080782 Beckman Coulter GEN.S and LH SlideMakers MHRA 2008/007/002/601/459 FSCA 2008/07/24 Beckman Coulter Hong Kong Ltd 2240 6150 SN080783 Roche cobas b 221 Software version 7.0 MHRA 2008/007/007/061/008 FSCA 2008/07/24 Roche Diagnotics (Hong Kong) Ltd. 2485 7510 SN080784 Applied Medical 15mm SeparatorR access systems MHRA 2008/007/008/061/006 FSCA 2008/07/24 N/A N/A SN080785 GE Healthcare Innova ® single plane cardiovascular Xray imaging systems MHRA 2008/006/018/601/424 FSCA 2008/07/24 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080786 Q’Straint Wheelchair QLK-100 Docking System MHRA 2008/004/009/401/001 FSCA 2008/07/24 N/A N/A SN080787 Stryker Navigation Pin, Ortholock EX Pin, and Ortholock QLK-100 Docking System MHRA 2008/006/024/051/008 FSCA 2008/07/24 Stryker China Ltd 2518 6915 SN080788 Bayer 5 second Contour blood glucose monitoring system MHRA 2008/007/003/601/463 FSCA 2008/07/24 Bayer Healthcare 2814 4836 SN080789 DEAS Heated Wire Circuits MHRA 2008/005/014/401/002 FSCA 2008/07/24 N/A N/A SN080790 Ventana Benchmark and Discovery Series Instruments MHRA 2008/007/011/061/017 FSCA 2008/07/24 N/A N/A Medical Device Control Office 34 Department of Health The Government of HKSAR SN080791 Otto Bock HealthcareKimba Inline Twin Mobility Base Units MHRA 2006/003/014/401/005 FSCA 2008/07/24 N/A N/A SN080792 Sunrise Medical Rumba Power Wheelchairs MHRA 2007/009/020/291/012 FSCA 2008/07/24 N/A N/A SN080793 Orthodocs Cocoon MHRA 2008/006/006/401/006 FSCA 2008/07/24 N/A N/A SN080794 Carina VT Homecare, intensive care and transport ventilators MHRA MDA/2008/055 MDA 2008/07/25 N/A N/A SN080795 Siemens Healthcare Laboratory analysers MHRA MDA/2008/056 MDA 2008/07/25 Siemens Ltd. 2810 7533 SN080796 Sunrise Medical Mermaid, Ranger & Dipper Bathing Products MHRA 2007/012/004/061/013 FSCA 2008/07/25 N/A N/A SN080797 Agfa IMPAX Clients 6.x MHRA 2008/006/013/061/001 FSCA 2008/07/25 AGFA Hong Kong Limited 2555 9421 SN080798 BD 60ml Luer-Lok Syringe (Recorder no. 309653) BD N/A Firm Initiated Field Action 2008/07/28 BD Asia Ltd (Hong Kong) 2722 5660 SN080799 Abbott Sequoia Spinal System Surgical Kits FDA Z-1479-2008 Class II 2008/07/28 Abbott Laboratories Ltd. 2806 4021 SN080800 Medtronic Intrathecal Catheter Pump Segment Revision Kit (Model no 8596SC) FDA Z-1308-2008 Class II 2008/07/28 SN080801 BHM Medical Infrared (IR) Hand Control System FDA Z-1233-2008 Class II 2008/07/28 Arjo Far East Ltd 2508 9553 SN080802 AMS In-Fast Ultra Kit with Polypropylene Suture (Ref 72403885) FDA Z-1235-2008 Class II 2008/07/28 N/A N/A SN080803 Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System and Oxy-PEEP High Flow O2 with PEEP FDA Z-1379-2008 to Z-1380-2008 Class II 2008/07/28 N/A N/A SN080804 Celsus Laboratories Heparin Lithium Lithium Lyophilized FDA Z-1917-2008 Class II 2008/07/28 N/A N/A SN080805 Sunrise Medical Manual and Powered Wheelchairs MHRA 2007/003/006/401/005 FSCA 2008/07/28 N/A N/A Medtronic International Ltd 2919 1300 SN080806 Abbott ARCHITECT AFP assay MHRA 2008/007/011/601/482 FSCA 2008/07/28 Abbott Laboratories Ltd. 2806 4021 SN080807 Hill-Rom Affinity® Four Birthing Bed MHRA 2008/007/011/061/018 FSCA 2008/07/28 N/A N/A SN080808 Karomed COMM-METAL Supreme Profiling Bed MHRA 2008/003/031/401/003 FSCA 2008/07/28 N/A N/A SN080809 Technical Service Consultants Urine collection bottle MHRA MDA/2008/057 MDA 2008/07/29 N/A N/A SN080810 Aidservice Medi-Tec Classic hoist Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo Test Fresenius Injectomat 50ml syringe MHRA MDA/2008/058 MDA 2008/07/31 N/A N/A MHRA 2008/007/021/061/008 FSCA 2008/07/31 N/A N/A MHRA 2008/007/015/061/014 FSCA 2008/07/31 N/A N/A FSCA 2008/07/31 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 SN080811 SN080812 SN080813 Philips Axis and Irix Gamma Cameras MHRA SN080814 Beckman Coulter Acetaminophen Reagent MHRA 2008/007/024/601/509 FSCA 2008/07/31 Beckman Coulter Hong Kong Ltd 2240 6150 SN080815 Stryker Triathlon TS Fermoral Trial FDA Z-1572-2008 to Z-1587-2008 Class II 2008/07/31 Stryker China Ltd 2518 6915 SN080816 Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software version 2.1 and 2.2 FDA Z-2016-2008 to Z-2033-2008 Class II 2008/07/31 Beckman Coulter Hong Kong Ltd 2240 6150 SN080817 Biomet Vanguard DCM CR Tibial Bearing FDA Z-1375-2008 to Z-1376-2008 Class II 2008/07/31 N/A N/A SN080818 Medline Eudur02 Oxygen Concentrator with Oxygen Monitor FDA Z-1473-2008 to Z-1474-2008 Class II 2008/07/31 N/A N/A SN080819 Philips A)Brilliance 64 Slice CT System-Main Unit, B) Brilliance CT Computed Tomography System, Health Canada 42936 Type II 2008/07/31 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 Medical Device Control Office 2008/007/014/061/004 35 Department of Health The Government of HKSAR SN080820 Philips A) Brilliance 40/64 Slice CT System, B) Brilliance CT Big Bore System-Main Unit, C) Brilliance CT System (16P), D) Brilliance 6/10/16 Slice CT System Health Canada 42569 Type II 2008/07/31 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 SN080821 Biomet Microfixation 1.5X5MM HT X-DR SCREW (Model 91-1505, 95-1505) Health Canada 42390 Type II 2008/07/31 Biomet Microfixation N/A SN080822 GE Datex Ohmeda A) Giraffe Warmer M1118179, B) Panda Warmer M1110875 Health Canada 42766 Type II 2008/07/31 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080823 Stryker Vertier Surgical Tables Health Canada 43004 Type II 2008/07/31 Stryker China Ltd 2518 6915 SN080824 Gambro Bioline, Hermoline Stryker 3.5MM Super 90-S Serfas Suction Probe (Model 0279-351300) GE OEC Secondary Collimator Filter On OEC 9600 (Model 2274014) Gambro Dasco SPA Phoenix Hemodialisis Delivery System (Model 6022933700) Health Canada 42406 Type II 2008/07/31 Gambro Hong Kong Ltd 2839 7010 Health Canada 42939 Type II 2008/07/31 Stryker China Ltd 2518 6915 Health Canada 42974 Type II 2008/07/31 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 42906 Type II 2008/07/31 Gambro Hong Kong Ltd 2839 7010 SN080825 SN080826 SN080827 SN080828 Philips A) Prism 1000S, B) Prism 1000XP, C) Prism 2000S, D) Prism 2000XP Health Canada 32350 Type II 2008/07/31 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 SN080829 Maquet Cardipulmonary AG Remote Control Unit (Model 939401) Health Canada 41063 Type II 2008/07/31 Maquet Hong Kong Ltd 2393 9511 SN080830 Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 005069-052-00) Health Canada 43002 Type II 2008/07/31 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN080831 Stryker Howmedica Ostenoics Corporation Scorpio 7000 Tibial Impactor Extractor (Model 3770-000) Health Canada 42982 Type II 2008/07/31 Stryker China Ltd 2518 6915 SN080832 Biomet 3I Navigator Surgical Guide Kit (SGKIT) Health Canada 42387 Type II 2008/07/31 Ositek Inc Ltd 8121 6601 SN080833 Fisher Scientific Formalin Neutral Buffered 10% (Model SF-100-20, SF100-4) Health Canada 42764 Type II 2008/07/31 N/A N/A SN080834 Wright Medical Technology Dynasty Trial Shell (Model 3300GG62, 3300GH64, 3300GH66, 3300GH68) Health Canada 42696 Type II 2008/07/31 N/A N/A SN080835 Becton Dickson BBL MGIT Mycrobacteria Growth Tubes, Bactec MGIT 960 PZA Kit Health Canada 41508 Type II 2008/07/31 BD Asia Ltd (Hong Kong) 2722 5660 Medical Device Control Office 36 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -June 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and SN080601 1 2) SN080602 Boston Scientific FilterWire EZT Embolic Protection Systems SN080603 SN080604 SN080605 SN080606 Hitachi Hi-Vision Ultrasound System Siemens ADVIA Centaur CP Thermogenesis Vapor Bypass Assembly (110v/220v) Varian TPS Eclipse SN080607 SN080609 Stryker Kinemax Plus Revision TS Tibial Insert Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903) AGA Medical Amplatzer PFO Occluder SN080610 Arrow Balloon Temporary Pacing Catheter Kit SN080611 BHM Ergiscake Scake abd Swivel Bar SN080608 SN080612 SN080613 Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and minipak Bio-Rad Varient B-Thalassemia Short Program Source of Information* Bausch and Lomb Boston Scientific Hong Kong Ltd MHRA MHRA MHRA Affaps MHRA N/A Date of Issue (YYYY/MM/DD) Firm Initiated Field Action 2008/06/02 Baush and Lomb Agent Contact Telephone No 2213 3371 N/A Firm Initiated Field Action 2008/06/02 Boston Scientific Hong Kong Ltd 2960 7136 2008/005/006/291/003 2008/005/013/041/007 2008/005/014/061/004 N/A FSCA FSCA FSCA N/A 2008/06/02 2008/06/02 2008/06/02 2008/06/03 N/A Siemens Ltd. N/A N/A N/A 2810 7533 N/A N/A Reference No. by Source Alert Type by Source 2008/005/009/121/006 FSCA 2008/06/04 Stryker China Ltd 2518 6988 Health Canada 42116 Type II 2008/06/05 Abbott Laboratories Ltd. 2806 4021 Health Canada 41996 Type II 2008/06/05 AGA Medical Corporation (Asia Pacific) N/A Health Canada 41991 Type II 2008/06/05 N/A N/A Health Canada 41995 Type II 2008/06/05 Arjo Far East Ltd 2508 9553 Health Canada 41858 Type II 2008/06/05 Bio-Rad Pacific Ltd. 2789 3300 Health Canada 42066 Type II 2008/06/05 Bio-Rad Pacific Ltd. 2789 3300 Health Canada 42115 Type II 2008/06/05 Cardinal Health N/A Health Canada Health Canada 42174 Type II 2008/06/05 Cook Asia (Hong Kong) Ltd. 2781 0232 41708 Type II 2008/06/05 N/A N/A N/A N/A SN080614 Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack and Othopedie-Fusion Posterieure SN080615 Cook Hilal Embolization Coils SN080616 Hill-Rom 100 Low Beds SN080617 Imaging Sciences I-CAT 17-19, 3D Dental Imaging System (Model 1-10-1-0) and I-Cat 3D Imaging System- Main Unit (Model 91400000-0000) Health Canada 42021 Type I 2008/06/05 SN080618 Johnson and Johnson Depuy Lupine BR Anchor With Orthocord Health Canada 42075 Type II 2008/06/05 Health Canada 42071 Type II 2008/06/05 SN080619 SN080620 Johnson and Johnson Ortho-Clinical Diagnostics Blood Gruping Reagent Anti-S Medtronic Lifepak Internal Defibillator Electrodes, Lifepak 9, 9p, 12 & 20 Int. Defibillator Handles Local Agent Johnson & Johnson Medical Hong Kong Johnson & Johnson Medical Hong Kong 2738 2818 2738 2818 Health Canada 40792 Type II 2008/06/05 Medtronic International, Ltd. 2919 1300 SN080621 Nova Biomedical Statstrip Glucose Hospital Meter Health Canada 42078 Type II 2008/06/05 N/A N/A SN080622 Oxoid Haemophilus Selective Agar Health Canada 42190 Type II 2008/06/05 N/A N/A SN080623 Philips Brilliance CT 16 Power Slice Health Canada 40156 Type II 2008/06/05 Philips Electronics Hong Kong Ltd. 2876 7525 SN080624 Philips Suresigns VS3 Vital Signs Monitor Health Canada 42049 Type II 2008/06/05 Philips Electronics Hong Kong Ltd. 2876 7525 SN080625 Pulmonetic Systems LTV 800, 950, 900 and 1000 Series Ventilators Health Canada 41278 Type II 2008/06/05 N/A N/A SN080626 Randox Triglycerides Health Canada 41875 Type II 2008/06/05 SN080627 Roche Elecsys Progesterone II Health Canada 41845 Type II 2008/06/05 SN080628 SN080629 Stryker SDC Ultra Tyco CT 9000 ADV Injector with Console Health Canada Health Canada 40955 42024 Type II Type II 2008/06/05 2008/06/05 N/A Roche Diagnostics (Hong Kong) Limited Stryker China Ltd COVIDIEN 2518 6988 3157 7220 SN080630 Tyco Optivantage DH Power Injection System Health Canada 42026 Type II 2008/06/05 COVIDEN 3157 7220 SN080631 Walter Lorenz Surgical Epker Osteotome (BOTH Slightly Curved and Straight) Health Canada 41577 Type II 2008/06/05 N/A N/A Medical Device Control Office 37 N/A 2485 7510 Department of Health The Government of HKSAR SN080632 Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II Skin Graft Carriers SN080633 SN080634 Health Canada 42114 Type II 2008/06/05 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 AquaJoy battery chargers (Serial no. 0638) MHRA 2007/011/026/401/005 FSCA 2008/06/06 N/A N/A IBG Immucor Galileo Echo MHRA 2008/005/015/061/008 FSCA 2008/06/06 N/A N/A SN080635 Innogenetics INNO-LIA Syphilis Score (Product code 80542) MHRA 2008/005/020/061/019 FSCA 2008/06/06 N/A N/A SN080636 Bausch & Lomb Zyoptix XP Microkeratome Motors (ZXP09183) MHRA 2008/005/008/181/011 FSCA 2008/06/10 Baush and Lomb 2213 3371 SN080637 Gambro Ultra filter U 8000 S (batch no. 8-3011-H-01) MHRA 2008/005/022/061/017 FSCA 2008/06/10 Gambro China Ltd 2839 7010 SN080638 Philips Motiva Remote Patient Management System MHRA 2008/005/013/061/017 FSCA 2008/06/10 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2008/005/021/061/004 FSCA 2008/06/10 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 MHRA 2008/003/022/601/200 FSCA 2008/06/11 N/A N/A MHRA 2008/003/031/061/005 FSCA 2008/06/11 GE Healthcare 2609 9233 SN080639 SN080640 Zimmer NexGen Complete Knee Solution Articular Surface Insertion Instrument CMS XiO/Focal SN080641 GE Healthcare OEC Uroview 2800, 9800 Plus, MiniView 6800, Flexiview 8800 Mobile C-Arm SN080642 Siemens Mevatron and Oncor Control Console Versions V6.5.079, V7.2.079 and V9.1.50 SN080643 Boston Scientific NAMIC MorseR Angiographic Manifold SN080644 CalMed Pericardial Sump SN080647 Cardinal Health U19 Socketed Integrated Circuit ("U19 IC"), Grey Inter-Unit Interface Connectors ("IUI") and U9 Socket Integrated Circuit ("U9 IC") GE Healthcare Proteus XR/a Radiographic System (Model Number 2259976) Siemens ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay SN080648 Accuray CyberKnife - Axum/Standard Treatment Couch SN080649 BD Obturators for Venflon, Insyte and Adsyte Pro Galemed EMS Ventilator Single use non rebreathing patient circuit (Product code: W196-002; Lot 20070709) SN080645 SN080646 SN080650 MHRA 2008/005/001/291/016 FSCA 2008/06/11 Siemens Ltd. 2810 7533 Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/06/12 Boston Scientific Hong Kong Ltd 2960 7136 FDA Z-1175-2008 to Z-1177-2008 Class II 2008/06/12 N/A N/A FDA Z-1710-2008 to Z-1712-2008 Class II 2008/06/12 Cardinal Health N/A FDA Z-0842-2008 Class II 2008/06/12 GE Healthcare 2609 9233 FDA Z-0580-2008 Class II 2008/06/12 Siemens Ltd. 2810 7533 Accuray Asia Ltd N/A Firm Initiated Field Action 2008/06/16 Accuray Asia Ltd 2247 8628 MHRA 2008/005/022/061/020 FSCA 2008/06/17 BD Asia Ltd (Hong Kong) 2575 8668 MHRA 2008/005/021/601/353 FSCA 2008/06/17 N/A N/A SN080651 GE Healthcare 3.0T Signa HD Scanner (3.0T Propeller T2 Flair application) MHRA 2008/005/030/061/027 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080652 GE Healthcare Advantage Workstation MHRA 2008/005/030/061/023 FSCA 2008/06/17 GE Healthcare 2609 9233 MHRA 2008/006/003/291/010 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080653 SN080654 GE Healthcare Centricity PASCS Software versions: 3.0.0X, 3.0.1X, 3.0.2.X AND 3.0.3X GE Healthcare DST-XL Carmera MHRA 2008/005/030/061/024 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080655 GE Healthcare Innova 2100IO, 3100/3100IQ and 4100/4100IQ Cardiovascular X-ray System MHRA 2008/005/030/061/034 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080656 GE Healthcare OEC 9900, 9800 and 8800 series MHRA 2008/005/030/061/025 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080657 GE Healthcare Pressure Sensitive Device (PSD) MHRA 2008/003/025/061/015 FSCA 2008/06/17 GE Healthcare 2609 9233 SN080658 GE Healthcare S/5 iCentral versions L-NET03, L-NETC03, L-NET05, L-NETC05 MHRA 2008/005/002/601/317 FSCA 2008/06/17 GE Healthcare 2609 9233 MHRA 2008/005/028/061/019 FSCA 2008/06/17 MHRA 2008/005/009/121/011 FSCA 2008/06/17 MHRA 2008/006/003/291/004 FSCA 2008/06/17 N/A Johnson & Johnson Medical Hong Kong Philips Electronics Hong Kong Ltd. 2738 2818 SN080661 Hansen Medical Artisan Control Catheter Johnson and Johnson Ethicon Endo-Surgery ENDOPATH ETS 35mm Philips X-Ray Systems with Monitor Ceiling Suspension 2876 7525 SN080662 Siemens ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems MHRA 2008/005/029/061/019 FSCA 2008/06/17 Siemens Ltd. 2810 7533 SN080659 SN080660 Medical Device Control Office 38 N/A Department of Health The Government of HKSAR SN080663 Specialised Orthotic Services Mojo, Maxi, Midi and Mini MHRA 2008/003/007/261/001 FSCA 2008/06/17 N/A N/A SN080664 Stryker Secure II, Epic and Zoom Beds MHRA 2008/003/006/061/012 FSCA 2008/06/17 Stryker China Ltd 2518 6988 SN080665 MHRA Boston Scientific Hong Kong Ltd MHRA 2008/005/015/401/001 FSCA 2008/06/19 B Braun Medical Hong Kong 2277 6125 N/A Firm Initiated Field Action 2008/06/19 Boston Scientific Hong Kong Ltd 2960 7136 SN080667 B Braun A/V Sets (Product Code 7210697) Boston Scientific NexStent Carotid Stent & MonorailR Delivery System Cardinal Health LTV ventilators 2008/006/009/291/011 FSCA 2008/06/19 Cardinal Health N/A SN080668 Covidien Thoraseal II chest drainage unit MHRA MDA/2008/040 MDA 2008/06/19 COVIDIEN 3157 7220 SN080669 GE Healthcare Precision 500D and Advantx Legacy R&F X-ray Systems MHRA 2008/005/030/061/029 FSCA 2008/06/19 GE Healthcare 2609 9233 SN080670 GE Healthcare Engstrom Carestation MHRA 2007/008/029/401/001 FSCA 2008/06/19 GE Healthcare 2609 9233 SN080671 Handicare Ibis XP power wheelchair MNRA 2007/010/009/401/003 FSCA 2008/06/19 N/A N/A SN080672 Nottingham Rehab Supplies Columbia Toilet Support MHRA 2007/012/018/401/006 FSCA 2008/06/19 N/A N/A SN080673 Baxa Exacta-Mix? 2400 Compounder MHRA 2008/006/012/601/405 FSCA 2008/06/23 N/A N/A SN080674 BioMerieux VIDAS HBs AG Ultra MHRA 2008/005/027/601/367 FSCA 2008/06/23 Biomerieux China Ltd (HK) 2356 7033 SN080675 Bio-Rad BIOPLEX 2200 SYPHILIS IgG Kit, EBV IgG KIT, CALIBRATORS, AND CONTROLS and MULTI-ANALYTE DETECTION SYSTEM FDA Z-1156-2008 to Z-1159-2008 Class II 2008/06/23 Bio-Rad Pacific Ltd. 2789 3300 SN080676 Boston Scientific Platinum PlusT Coronary Guidewire N/A Firm Initiated Field Action 2008/06/23 Boston Scientific Hong Kong Ltd 2960 7136 SN080677 Boston Scientific Safety PEG Kits SN080678 SN080680 Conmed DetachaTip Surgical Instruments GE LOGIQ3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2 Huntleigh Healthcare Arjo Malibu SN080681 SN080666 SN080679 Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd MHRA N/A Firm Initiated Field Action 2008/06/23 Boston Scientific Hong Kong Ltd 2960 7136 2008/006/009/291/009 FSCA 2008/06/23 N/A N/A FDA Z-1155-2008 Class II 2008/06/23 GE Healthcare 2609 9233 MHRA 2007/009/007/301/001 FSCA 2008/06/23 Arjo Far East Ltd 2508 9553 Kimal Safety Fistula Needle MHRA 2008/006/011/601/402 FSCA 2008/06/23 N/A N/A SN080682 Metrax Primedic Charger Basis MHRA 2008/006/011/291/005 FSCA 2008/06/23 N/A N/A SN080683 PDG Bentley Manual Tilt Wheelchair MHRA 2008/002/005/301/001 FSCA 2008/06/23 N/A N/A SN080684 Roche Diagnostics COBAS Integra 400 systems MHRA 2008/006/005/291/003 FSCA 2008/06/23 Roche Diagnostics (Hong Kong) Ltd 2485 7510 SN080685 Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 MHRA 2008/006/009/061/007 FSCA 2008/06/23 Siemens Ltd 2810 7533 SN080686 MHRA 2008/006/013/291/011 FSCA 2008/06/23 St Jude Medical 2996 7601 MHRA 2008/006/013/601/408 FSCA 2008/06/23 N/A N/A SN080688 St Jude Medical Livewire TC Ablation Catheter ThermoFisher Scientific PB0124A Columbia agar with chocolated horse blood Unomedical OP tubing (Lot No 182281) MHRA 2008/001/022/401/007 FSCA 2008/06/23 N/A N/A SN080689 Varian Medical Systems VARIS Vision/System 6.5 MHRA 2008/006/002/291/007 FSCA 2008/06/23 N/A N/A SN080690 Waldemar Link Megasystem-C Modular Components MHRA 2008/004/010/061/011 FSCA 2008/06/23 N/A N/A SN080691 Coloplast Balloon Nephrostomy catheter with introducer (Ref. no. AJ6812 - AJ6822) N/A Firm Initiated Field Action 2008/06/25 Coloplast (Hong Kong) Ltd 3628 7428 N/A Firm Initiated Field Action 2008/06/26 Boston Scientific Hong Kong Ltd 2960 7136 SN080687 Coloplast (Hong Kong) Ltd Boston Scientific Hong Kong Ltd SN080692 Boston Scientific implantables devices, ICD and CRT-D SN080693 Computerized Medical Systems XIO Radiation Treatment Planning System Health Canada 42336 Type II 2008/06/27 N/A N/A SN080694 Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE RADIOLOGY V.3.5, IVAULT V.3.5) Health Canada 42273 Type II 2008/06/27 Philips Medical Systems Regional Office (Asia Pacific) 2821 5480 Medical Device Control Office 39 Department of Health The Government of HKSAR SN080695 Gambro cartridge blood set (Model 003410-510, 003410-710, 0141080XXXC) Health Canada 42069 Type II 2008/06/27 Gambro Hong Kong Ltd 2839 7010 SN080696 Maquet HL 30 Perfusion System Health Canada 41066 Type II 2008/06/27 Maquet Hong Kong Ltd 2393 9511 SN080697 Stryker Infravision Urethral Kit (Model 0220-180-516) Health Canada 42415 Type II 2008/06/27 Stryker China Ltd 2518 6915 SN080698 Terumo Level Sensor II Pads, Gel included Health Canada 41365 Type II 2008/06/27 TERUMO CHINA (H.K.) LTD. 2866 0811 SN080699 Medtronic Affinity NT Hollow Fiber Oxygenator Model CB511) Health Canada 42402 Type II 2008/06/27 Medtronic-Mediland (Taiwan) Ltd 2919 1300 SN080700 GE Advantx LCLP+ Bi Plane Cardiac System, Advantx LCN+Angiographic System, Innova 2000 Cardiovascular System, Innova 2100 IQ Digital Imaging System, Innova 4100IQ Tables Health Canada 40766 Type II 2008/06/27 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080701 ITC Protime Microagulation System (Model PROTIMEPST) Health Canada 39337 Type II 2008/06/27 N/A N/A SN080702 Thermogenesis Autoxpress Platform System (Model 8-5101-0) Health Canada 41781 Type II 2008/06/27 N/A N/A SN080703 Immucor Corqc Test System, Panoscreen I/II/III (Model) Health Canada 42166 Type II 2008/06/27 N/A N/A Medical Device Control Office 40 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -May 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SN080501 Abbott CELL-DYN Hemoglobin Reagent Syringe (Product Descriptiion: CDS HGB SRNGW/BU) FDA Z-1165-2008 Class II 2008/05/02 Abbott Laboratories Ltd. 2806 4021 SN080502 Siemens ACUSON Sequoia Diagnostic Utrasound System (Material Number 8245875, 8246951,8267697) FDA Z-0661-2008 Class II 2008/05/02 Siemens Ltd. 2810 7533 SN080503 Respironics Various Devices and Accessories FDA Z-1055-2008 to Z-1093-2008 Class II 2008/05/02 CELKI Medical Company 2268 9258 SN080504 Truelife walking frames for adults and children MHRA MDA/2008/031 MDA 2008/05/02 N/A N/A Baush and Lomb N/A Firm Initiated Field Action 2008/05/05 Baush and Lomb 2213 3371 Accuray Asia Ltd N/A Firm Initiated Field Action 2008/05/05 Accuray Asia Ltd 2247 8628 MHRA 2007/011/020/061/002 FSCA 2008/05/07 N/A N/A MHRA 2008/004/011/061/016 FSCA 2008/05/07 N/A N/A FDA Z-1106-2008 Class II 2008/05/08 Stryker China Ltd 2518 6988 SN080510 GE Healthcare Centricity PACS RA1000 Workstation FDA Z-1104-2008 Class II 2008/05/08 GE Healthcare 2609 9233 SN080511 Siemens Coherence AG Therapist FDA Z-0971-2008 to Z-0981-2008 Class II 2008/05/08 Siemens Ltd. 2810 7533 SN080512 Seradyn QMS Vancomycin Reagents (Part Nimber 0373589) FDA Z-1102-2008 Class II 2008/05/08 N/A N/A SN080513 Siemens Advia Centaur System and Advia Centaur XP System Health Canada 41756 Type II 2008/05/08 Siemens Ltd. 2810 7533 SN080514 Siemens Dimension TPSA Flex Reagent Cartridge Health Canada 41721 Type II 2008/05/08 Siemens Ltd. 2810 7533 SN080515 Siemens Mevatron and Oncor Linear Accelerators Health Canada 34725 Type II 2008/05/08 Siemens Ltd. 2810 7533 SN080516 Medtronic Hall Easy-Fit Prosthetic Heart VALVE (Aortic and Mitral) Health Canada 41777 Type II 2008/05/08 Medtronic International, Ltd. 2919 1300 SN080517 Medtronic Bravo PH Capsule With Delivery System Health Canada 39316 Type II 2008/05/08 Medtronic International, Ltd. 2919 1300 SN080518 Varian Medical Clinac High and Low Engery Health Canada 41305 Type II 2008/05/08 Varian Medical Systems Pacific Inc. N/A SN080519 Cardinal Health Custom Sterile Total Joint Pack Health Canada 41543 Type II 2008/05/08 N/A N/A 2519 9182 N/A SN080505 Bausch & Lomb XP MicroKeratome motors SN080506 Accuray CyberKnife Robotic Radiosurgery System MultiPlan Treatment Planning Sofetware (Catalog No 022986) SN080507 Phonak Rubber Dome BTE hearing instruments SN080508 Edwards Lifesciences Aquarius Regular Haemofiltration Machine with software version 4.01.11 SN080509 Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306554) SN080520 Convatec Gentle Touch 70mm Colo/Ileo PostOp Kit Health Canada 41524 Type II 2008/05/08 Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong) SN080521 National Biological Houva III Health Canada 41407 Type II 2008/05/08 N/A Medical Device Control Office 41 Department of Health The Government of HKSAR SN080522 Biosense Webster Lasso Variable Deflectable CIR Map Catheter SN080523 Levitronix CentriMag Systems Health Canada 41774 Health Canada Type II 2008/05/08 N/A N/A 41786 Type II 2008/05/08 N/A N/A Medtronic International Ltd N/A Firm Initiated Field Action 2008/05/08 Medtronic International, Ltd. 2919 1300 Health Canada 41574 Type II 2008/05/08 Biomerieux (Hong Kong) 2356 7033 Health Canada 41659 Type II 2008/05/08 Johnson & Johnson Medical Hong Kong 2738 6000 SN080527 BHM Medical Medi-Lifter II Plus Patient Lift and Summit Health Canada 41705 Type I 2008/05/08 N/A N/A SN080528 A.L.N. Vena Cave Filter / Introduction Kit Health Canada 41639 Type I 2008/05/08 N/A N/A SN080529 Biomet 3i Certain Microminiplant Healing abutment Health Canada 41552 Type II 2008/05/08 Ositek Inc Ltd 8121 6601 SN080530 Bio-Rad Liquicheck Sedimentation Rate Control Health Canada 41293 Type II 2008/05/08 Bio-Rad Pacific Ltd. 2789 3300 MHRA 2008/004/009/301/001 FSCA 2008/05/08 N/A N/A Convatec N/A Firm Initiated Field Action 2008/05/09 Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong) 2519 9182 MHRA 2008/004/008/291/002 FSCA 2008/05/09 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 2008/05/14 Boston Scientific Hong Kong Ltd 2960 7128 2008/05/14 Boston Scientific Hong Kong Ltd 2960 7128 SN080524 Medtronic Heparin-Coated products SN080525 Biomerieux Vitek GPS Quinupristin/Dalfoprist Cards SN080526 Johnson and Johnson Ortho-Clinical Diagnostics Vitros 5,1 FS Chemistry System SN080531 Aidapt Isis shower board (Code No. R232) SN080532 Covatec Active Life Little One (20917) Zimmer Hemovac, HAS, Sergivac, Infection Control and MiniSN080533 Hemovac Systems SN080534 Boston Scientific iReview SoftwareVer1.0 SN080535 Boston Scientific OMG Connector-A Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Firm Initiated Field Action Firm Initiated Field Action N/A N/A Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & BuiltSN080536 in Printer, 6004 MHRA 2008/004/015/061/013 FSCA 2008/05/14 Goodwin Health Care Holdings Ltd 2408 8838 SN080537 P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable) MHRA 2007/012/022/601/001 FSCA 2008/05/14 Ultra Care Company Ltd N/A SN080538 Fisher & Paykel Healthcare Patient Warmers MHRA 2008/004/022/061/020 FSCA 2008/05/14 N/A N/A SN080539 Gambro Spectra Optia Apheresis System MHRA 2008/004/023/061/013 FSCA 2008/05/14 Gambro China Ltd 2839 9710 SN080540 Thoratec HeartMate II LVAS Fisher Healthcare Sure-Vue Serum/Urine hCD-STAT (Catalog no. SN080541 FHC-A202, Product Codes: FHC-A202-KFI3O and FHC-A202KFI5O) SN080542 Medefil Heparin I.V. Flush Syringe MHRA 2008/004/023/291/003 FSCA 2008/05/14 N/A N/A FDA Z-1118-2008 Class II 2008/05/15 N/A N/A FDA Z-1543-2008 to Z-1545-2008 Class II 2008/05/15 N/A N/A SN080543 Siemens ADVIA Centaur HAV IgM FDA Z-1119-2008 Class II 2008/05/15 Siemens Ltd. 2810 7533 SN080544 Philips Healthcare iSite PACS image management system FDA Z-1141-2008 Class II 2008/05/15 Philips Electronics Hong Kong Ltd. 2332 4455 FDA Z-1594-2008 to Z-1602-2008 Class II 2008/05/15 COVIDIEN 3157 7244 2008/05/16 Boston Scientific Hong Kong Ltd 2960 7128 2008/05/16 Boston Scientific Hong Kong Ltd 2960 7128 SN080545 Tyco Healthcare Monoject Prefill Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation SN080546 Device SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes Medical Device Control Office Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Firm Initiated Field Action Firm Initiated Field Action N/A N/A 42 Department of Health The Government of HKSAR SN080548 Baxter HomeChoice Automated Peritoneal Dialysis System (Software v.10.210) SN080549 Boston Scientific iLab UltraSound Imaging System Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/05/16 MHRA 2008/004/024/061/011 FSCA Baxter Healthcare Ltd 2807 8500 2008/05/19 Boston Scientific Hong Kong Ltd 2960 7128 2738 6000 SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps MHRA 2008/004/021/061/008 FSCA 2008/05/19 Johnson & Johnson Medical Hong Kong SN080551 Respironics Humidifier Chambers MHRA 2008/003/028/401/001 FSCA 2008/05/19 CELKI Medical Company 2268 9258 SN080552 Firstar Plastic Vaginal Speculum MHRA 2007/011/014/401/001 FSCA 2008/05/19 Firstar Healthcare Co., Ltd N/A SN080553 Dragonmobility Power-chairs MHRA 2008/001/017/301/001 FSCA 2008/05/19 N/A N/A SN080554 Waldemar Link Megasystem-C Modular Components MHRA 2008/004/010/060/011 FSCA 2008/05/21 N/A N/A Biotrin Nephkit Alpha GST EIA (Product Code: BIO66NEPHA, Lot SN080555 no 58KT036) MHRA 2008/004/030/061/013 FSCA 2008/05/21 N/A N/A SN080556 Chiltern Invadex Shower Trolleys and Shower/Changing Stretchers MHRA 2007/012/033/401/004 FSCA 2008/05/21 N/A N/A Smiths Medical Graseby Omnifuse and Omnifuse PCA Syringe SN080557 Pumps MHRA 2008/003/006/061/008 FSCA 2008/05/21 Goodman Medical Supplies Ltd 2332 4455 SN080558 Welch Allyn AED 10 MHRA 2008/004/016/061/023 FSCA 2008/05/21 N/A N/A SN080559 VIASYS AVEA Ventilator FDA Z-0982-2008 to Z-0986-2008 Class II 2008/05/22 VIASYS Healthcare (Hong Kong) Ltd 6305 5575 SN080560 Cardinal Health AirLife Infant Ncpap System Driver FDA Z-0987-2008 Class II 2008/05/22 N/A N/A Siemens Syngo US Workplace Picture Archiving and SN080561 Communication System, software version 2.0, 94043 FDA Z-1138-2008 Class II 2008/05/22 Siemens Ltd. 2810 7533 FDA Z-1105-2008 Class II 2008/05/22 Stryker China Ltd 2518 6988 FDA Z-1103-2008 Class II 2008/05/22 Abbott Laboratories Ltd. 2806 4021 SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor MHRA 2008/004/024/061/014 FSCA 2008/05/22 Medtronic International, Ltd. 2919 1300 Stryker Pegless Universal Scorpio Notch Guide (Catalog no 8000SN080565 3303) and Universal Scorpio Notch Preparation Guide (Catalog no 7650-3363) MHRA 2008/004/003/061/010 FSCA 2008/05/22 Stryker China Ltd 2518 6988 MHRA 2008/004/029/061/002 FSCA 2008/05/22 Dade Behring HK Ltd., A Siemens Company 2810 7533 SN080567 B Braun Dialog+ Machines with DF Option MHRA 2008/004/023/061/009 FSCA 2008/05/22 B Braun Medical Hong Kong 2277 6611 SN080568 Sysmex CS-Series - Coagulation Analyser (all versions) MHRA 2008/004/025/061/001 FSCA 2008/05/22 N/A N/A SN080569 Biotrin Urinary Collagen IV EIA (Catalog Code BIO83) MHRA 2008/004/001/061/002 FSCA 2008/05/22 N/A N/A SN080570 Masimo Rainbow Rad-57 Pluse CO-Oximeter MHRA MDA/2008/033 MDA 2008/05/22 N/A SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR) MHRA 2008/004/030/601/310 FSCA 2008/05/23 N/A Dade Behring HK Ltd., A Siemens Company Dade Behring HK Ltd., A Siemens Company Dade Behring HK Ltd., A Siemens Company SN080562 Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 6541-4805) Abbott White Blood Cell (WBC) Reagent-Part A used with the SN080563 CELL-DYN 4000 and CELL-DYN Sapphire Systems , Red cell lysing reagent (List No. 01H77-01) SN080566 Dade Behring Enzygnost Toxoplasmosis/IgG (OUNA27) in combination with Sample Buffer POD lot 426707 Dade Behring N Latex CDT Kit (OPCS03) and N Latex CDT (kit) SN080572 (OPCS05) MHRA 2008/004/029/061/003 FSCA 2008/05/23 SN080573 Dade Behring Dimension Clinical Chemistry System MHRA 2008/004/017/601/273 FSCA 2008/05/23 Medical Device Control Office 43 2810 7533 2810 7533 2810 7533 Department of Health The Government of HKSAR SN080574 Beckman Coulter Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System and UniCel DxC 600i System MHRA 2008/004/028/601/297 FSCA 2008/05/23 Beckman Coulter 2240 6260 SN080575 Siemens ACUSON Antares, Ultrasound System Health Canada 41792 Type II 2008/05/23 Siemens Ltd. 2810 7533 SN080576 Biosite Triage MeterPro Health Canada 41867 Type II 2008/05/23 N/A N/A SN080577 Cardinal Health Custom Sterile Hip Pack Health Canada 41842 Type II 2008/05/23 Cardinal Health N/A Health Canada 2008/05/23 Draeger Medical Hong Kong Ltd. 2877 3077 2008/05/23 Johnson & Johnson Medical Hong Kong 2738 6000 SN080578 Draeger Medical Oxylog 3000 41844 Type II Johnson & Johnson Medical Hong Kong N/A Firm Initiated Field Action Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/05/26 Boston Scientific Hong Kong Ltd 2960 7136 SN080581 ThermoFisher Scientific LAB VISION Pretreatment Module MHRA 2008/005/009/121/004 FSCA 2008/05/26 N/A N/A SN080582 Invacare Harrier Heavy Duty (HD) Powered Wheelchairs MHRA 2007/010/018/061/002 FSCA 2008/05/26 N/A N/A FDA Z-1110-2008 to Z-1117-2008 Class II 2008/05/29 N/A N/A SN080584 Park House Healthcare VERSAtec Back MHRA 2007/009/012/301/002 FSCA 2008/05/29 N/A N/A SN080585 BPR Medical FireSafe Cannula Valves (Firebreak) MHRA 2008/004/008/061/008 FSCA 2008/05/29 N/A N/A SN080586 Gambro Hospal Blood Set MHRA 2008/005/013/061/013 FSCA 2008/05/29 Gambro China Ltd 2839 7010 SN080587 Invacare Storm and Storm True Track (TT) wheelchairs MHRA MDA/2008/035 MDA 2008/05/29 N/A N/A SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist SN080580 Boston Scientific RotaWire Guidewire SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set Medical Device Control Office 44 Department of Health The Government of HKSAR cal Device Safety Alerts -April 2008 and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SN080401 Smith & Nephew Medullary Exchange Tube (Product Code 415113, Lot 07AM1186) MHRA 2007/004/019/601/816 FSCA 2008/04/03 Smith & Nephew Healthcare Ltd. 2648 7700 SN080402 Varian CT/MR Ring and Tandem Combination Applicator Set (AL13017000) MHRA 2008/003/017/061/004 FSCA 2008/04/03 Varian Medical Systems Pacific Inc. 2724 2836 SN080403 Edwards Lifesciences VAMP Jr MHRA 2008/003/017/061/015 FSCA 2008/04/03 N/A N/A SN080404 BrainLAB BrainScan MHRA 2008/003/013/061/024 FSCA 2008/04/03 N/A N/A FDA Z-1050-2008 Class II 2008/04/03 Medtronic International, Ltd. 2919 1300 FDA Z-1310-2008 to Z-1313-2008 Class II 2008/04/03 Terumo China (H.K.) Ltd. 2866 0811 FDA Z-1353-2008 to Z-1360-2008 Class II 2008/04/03 N/A N/A AMO Asia Limited N/A Firm Initiated Field Action 2008/04/07 AMO Asia Limited 2480 3330 SN080405 LIFEPAK 20 Defibrillator/monitor SN080406 Terumo Cardiovascular Procedure Kit (P/N 70932-01, 64789-01, 70295-02, 70579-04) SN080407 Pointe Scientific Liquid Alkaline Phosphatase Reagent Set SN080408 AMO WHITESTAR SIGNATURE Phacoemulsification System (NGP680300) SN080409 ConMed Linvatec Hall Surgical Blades, Sterile, Single-use, packaged in Bilsters MHRA 2008/003/017/291/001 FSCA 2008/04/08 N/A N/A SN080410 RITA Starburst XLie Radiofrequency Ablation Probe and Talon Radiofrequency Ablation Probe MHRA 2008/003/019/061/007 FSCA 2008/04/08 N/A N/A MHRA MDA/2008/023 MDA 2008/04/09 Hospira Ltd 2285 8382 SN080412 Skryker ACL Workstation slider (Model Number: 234-010-503) FDA Z-1107-2008 Class II 2008/04/10 Stryker China Ltd 2518 6988 SN080413 Hill-Rom Affinity 4 Birthing Bed (Model P3700B) FDA Z-0617-2008 Class II 2008/04/10 N/A N/A SN080414 Siemens Mevatron, Oncor, Primus Linear Accelerators FDA Z-1394-2008 to Z-1407-2008 Class II 2008/04/10 Siemens Ltd. 2810 7533 SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled MHRA 2008/003/013/291/008 FSCA 2008/04/10 N/A N/A Stryker Scorpio Knee Femoral Component (Catalog No. 70-5211R, 71-5211R, Lot Code: KNAMED, V8WMED) MHRA 2008/003/013/291/014 FSCA 2008/04/11 Stryker China Ltd 2518 6988 MHRA 2008/001/003/061/013 FSCA 2008/04/11 N/A N/A MHRA 2008/003/012/061/002 FSCA 2008/04/11 N/A N/A MHRA 2008/002/029/601/139 FSCA 2008/04/14 N/A N/A MHRA 2008/003/025/061/013 FSCA 2008/04/14 Abbott Laboratories Ltd. 2806 4021 SN080411 Hospira Butterfly winged needle infusion set SN080416 SN080417 Medivance Instruments Velopex Extra X SN080418 Thermogenesis Disposable Processing Set for the AXP System 85101 SN080419 Elekta Stereotactic Body Frame CT and MRI indicators SN080420 Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part No. 80111-01) Medical Device Control Office 45 Department of Health The Government of HKSAR SN080421 Arcomedical 3101-TJ (FSB123) Blood Set with Lower Y site (Batches C8446) SN080422 Boston Scientific RX Plastic Biliary Stents SN080423 Boston Scientific Precision Implantable Pluse Generator (UPN M365SC11100) SN080424 Boston Scientific Mach 1 Guide Catheter SN080425 Boston Scientific Single-Use Rotatable Snares SN080426 Boston Scientific SteeroCath-Dx and SteeroCath-T Catheters Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent SN080427 with Delivery System Stent System SN080428 Boston Scientific Smash Balloon Dilation Catheter SN080429 Boston Scientific Various Products SN080430 Zimmer Hemovac Wound Drainage Device Infection Control Kits SN080431 Medtronic AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System MHRA 2008/003/013/601/181 FSCA 2008/04/14 N/A N/A Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/04/15 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/15 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/15 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/15 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/15 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/16 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/16 Boston Scientific Hong Kong Ltd 2960 7128 2008/04/16 Boston Scientific Hong Kong Ltd 2960 7128 Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Boston Scientific Hong Kong Ltd Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action Firm Initiated Field Action N/A N/A N/A N/A N/A N/A N/A FDA Z-1448-2008 to Z-1458-2008 Class II 2008/04/17 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 FDA Z-0689-2008 Class II 2008/04/17 Medtronic International, Ltd. 2919 1300 Myelotec Steerable Video Guided Catheter (Product Code 2000 SN080432 and 2010) FDA Z-0586-2008 to Z-0587-2008 Class II 2008/04/17 N/A N/A SN080433 CES Ultra, Cranial Electrotherapy Stimulator FDA Z-0712-2008 Class II 2008/04/17 N/A N/A Ormco Grengloo (Unidose Tips), Bracket adhesive and tooth SN080434 conditioner (Part Number 740-0322) FDA Z-0916-2008 Class II 2008/04/17 L&S Dental Supplies Limited 2815 8115 SN080435 Nonin Model 2500 PalmSAT handheld pluse Oximeter FDA Z-0843-2008 Class II 2008/04/17 N/A N/A MHRA 2008/003/031/291/008 FSCA 2008/04/17 Abbott Laboratories Ltd. 2806 4021 SN080436 Abbott Vascular Xact Rapid Exchange Carotid Stent System SN080437 PROACT Silicone Disposable Armoured LMA SAD-LA6320, SADLA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350 MHRA 2007/012/021/401/014 FSCA 2008/04/18 N/A N/A SN080438 Siemens Medical IMMULITE 2000 CEA kit L2KCE2,6 lot 232 and IMMULITE 2500 CEA kit L5KCE2,6 lot 111 MHRA 2008/002/028/601/134 FSCA 2008/04/18 Siemens Ltd. 2810 7533 SN080439 Huntleigh Healthcare Well-Shin WS-023 power lead adapters MHRA MDA/2008/027 MDA 2008/04/18 N/A N/A SN080440 Huntleigh Healthcare Birthright birthing bed mattresses MHRA MDA/2008/026 MDA 2008/04/18 N/A N/A SN080441 BHM Medical Maxi Sky 600, V4 and V4i Ceiling Lifts Health Canada 41375 Type II 2008/04/21 N/A N/A SN080442 Smiths Medical BCI 3180 Pulse Oximeter (Model 3180) Health Canada 41371 Type II 2008/04/22 Goodwin Health Care Holdings Ltd 2408 8838 SN080443 Biohorizons Implant System Ratchet Extender (Model # 300-205) Health Canada 41433 Type II 2008/04/22 Specialists' Dental Supplies Limited 9656 7000 Health Canada 41374 Type II 2008/04/22 Specialists' Dental Supplies Limited 9656 7000 SN080444 Biohorizons Single-Stage Implant System 122-800 Kit (Model 122800) Medical Device Control Office 46 Department of Health The Government of HKSAR SN080445 Elekta PrecisePlan (Model # MRT 7131, MRT 7161) Health Canada 41295 Type II 2008/04/22 N/A N/A SN080446 Elekta iViewGT Electronical Portal Imaging (Model XRT 1261) Health Canada 41295 Type II 2008/04/22 N/A N/A Health Canada 41158 Type II 2008/04/22 N/A N/A Health Canada 41183 Type II 2008/04/22 N/A N/A Somagen IgM HRP ELISA Kit (Model LAPL-K-HRP-001GM, LAPLK-HRP-001M) Tornier Aequalis Shoulder (Kelled Glenoid and Cemented Glenoid) SN080448 and Latitude Elbow Prosthesis Cap, Radial Head and Ulnar Compon SN080449 Meridian Bioscience Immunocard Toxins A & B SN080447 Health Canada 41330 Type II 2008/04/22 N/A N/A SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103) MHRA 2008/004/003/061/016 FSCA 2008/04/23 N/A N/A SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E MHRA 2008/002/021/061/018 FSCA 2008/04/23 N/A N/A SN080452 MEDNET TOPS OUS Fusion System MHRA 2008/001/025/291/005 FSCA 2008/04/23 N/A N/A Medfor S400 and S227 Femoral Head Storage Pot, Labelled, SN080453 double wrapped MHRA 2008/002/029/601/140 FSCA 2008/04/23 N/A N/A MHRA SN080454 Merlin Medical Disposable pen torch (Model no. W2137) MDA/2008/028 MDA 2008/04/23 N/A N/A GE Medical Systems Hong Kong Ltd. N/A Firm Initiated Field Action 2008/04/24 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080456 Cook Peel-Away Introducer set and Cook TPN Lumen Catheter set FDA Z-0892-2008 to Z-0904-2008 Class II 2008/04/24 Cook Asia (Hong Kong) Ltd. 2781 0232 SN080457 BioRad BioPlex 2200 Instrument FDA Z-0575-2008 Class II 2008/04/24 Bio-Rad Pacific Ltd. 2789 3300 SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes) Medical Device Control Office 47 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -March 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SN080301 Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit (CATALOG# IB0900G) Health Canada 40290 Type II 2008/03/03 N/A N/A SN080302 Zoll Medical E Series Debribillator with 12 Lead ECG Health Canada 40588 Type II 2008/03/03 N/A N/A SN080303 Stryker Howmedica Modular Replacement System, Distal Fem Health Canada 39226 Type I 2008/03/03 Stryker China Ltd 2518 6988 SN080304 Walter Lorenz Surgical Pectus Table Top Bender (Trading as: Biomet Microfixation) Health Canada 39755 Type II 2008/03/03 N/A N/A SN080305 Balt Extrusion Goldbal Detachable Balloons Health Canada 39555 Type II 2008/03/03 N/A N/A SN080306 Roche Accutrend GC Health Canada 39757 Type II 2008/03/03 Roche Diagnostics (Hong Kong) Limited 2485 7510 SN080307 Stryker Howmedica Trident acetabular shell and Trident hemispherical shell Health Canada 40619 Type II 2008/03/03 Stryker China Ltd 2518 6988 SN080308 Elekta Precise Plan Health Canada 40747 Type II 2008/03/03 N/A N/A SN080309 Elekta Precise Treatment Table Health Canada 40457 Type II 2008/03/03 N/A N/A SN080310 Elekta Leksell GammaPlan 8.0 Health Canada 40497 Type II 2008/03/03 N/A N/A SN080311 Abbott Cell Dyn Sapphire Analyzer (model # 08H00-01) Health Canada 40557 Type II 2008/03/03 Abbott Laboratories Ltd. 2806 4021 SN080312 B Braun Aesculap FT420T-FT430T Caspar Aneurysm Clips APP Health Canada 40744 Type I 2008/03/03 B. Braun Medical (HK) Ltd 2277 6611 SN080313 Conmed Endoscopic Ligating Clip Applier (ELC) Health Canada 39961 Type II 2008/03/03 N/A N/A SN080314 Technidata TD-Synergy V03.11.A Health Canada 40014 Type II 2008/03/03 N/A N/A SN080315 BD Luer Slip Syringe Products (REF 301294, 301295, 30020) MHRA 2008/002/001/181/009 FSCA 2008/03/05 BD 2518 6988 SN080316 Terumo Weighed Flexible Sucker (Ref Code 804113) MHRA 2008/002/020/061/003 FSCA 2008/03/05 Terumo China (H.K.) Ltd. 2866 0811 SN080317 Trinity Biotech Bartels Viral Respiratory Screening and Identification Kit (Prodcut Code B1029-86) MHRA 2008/002/021/291/008 FSCA 2008/03/05 N/A N/A SN080318 WMS Disposable Pen Torch W2137 (Batch Q01403, Q01408, Q01371) MHRA 2007/011/006/401/010 FSCA 2008/03/05 N/A N/A SN080319 Baush and Lomb ReNu Comfort Drops (Lot No 225747 and 225757) MHRA 2008/002/011/061/014 FSCA 2008/03/05 Baush and Lomb 2213 3371 SN080320 Arjo Ambulift Hoist MHRA MDA/2008/010 MDA 2008/03/05 N/A N/A SN080321 Advanced Bionics Precision Implantable Pluse Generator Kit (Model No. SC-1110) FDA Z-0960-2008 to Z-0961-2008 Class II 2008/03/06 N/A N/A Medical Device Control Office 48 Department of Health The Government of HKSAR SN080322 American Medical Systems, Inc., GreenLight HPS Fiber Optic (ADDStat) (Part Number: 0010-2090B) FDA Z-0131-2008 Class II 2008/03/06 N/A N/A SN080323 TENET Medical Engineering Wrist Stabilization Kit FDA Z-0577-2008 to Z-0579-2008 Class II 2008/03/06 N/A N/A SN080324 Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor (Catalog No. 50-10185) FDA Z-0674-2008 Class II 2008/03/06 N/A N/A SN080325 Philips Medical Allura XPER FD10 and FD10/10 with AD7 MHRA 2008/002/021/291/001 FSCA 2008/03/12 Philips Electronics Hong Kong Ltd. 2876 7525 SN080326 VNS Therapy Demipulse Generator (103) and Demipulse Duo Generator (104) MHRA 2008/002/021/061/003 FSCA 2008/03/12 N/A N/A SN080327 Smiths Medical Logical, NovaTrans, and Transtar Invasive Pressure Monitoring Kits with Trigger Flush Device MHRA 2008/002/025/291/022 FSCA 2008/03/12 N/A N/A SN080328 Biomet Vanguard Width Checker (Item Number # 32-487062) MHRA 2008/002/019/061/010 FSCA 2008/03/12 N/A N/A SN080329 Zimmer Pulsavac Plus Wound Debridement System, Pulsavac Plus AC Component Kit, Pulsavac Fan Spray Kit and Hip Kit FDA Z-0856-2008 to Z-0865-2008 Class II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN080330 Stryker Disposable StrykeProbe 32 cm L-Tip and Spatula Tip FDA Z-0573-2008 to Z-0574-2008 Class II 2008/03/19 Stryker China Ltd 2518 6988 SN080331 Siemens ACUSON Aspen Diagnostic Ultrasound System (Model Number 8247887) FDA Z-0719-2008 Class II 2008/03/19 Siemens Ltd. 2810 7533 SN080332 Zimmer Allofit Shell Size 50 (Model 4244, Lot 2406181) Health Canada 39593 Type II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN080333 Zimmer Hemovac Infection Control Kits Health Canada 40972 Type II 2008/03/19 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SN080334 Siemens Syngo Dynamica (Model 100 90 679; Serial # 92241, 93477, 95243, 95248) Health Canada 40885 Type II 2008/03/19 Siemens Ltd. 2810 7533 SN080335 Siemens Leonardo Workstation (Model 7129534, Serial # 10413, 10434, 10599) Health Canada 40580 Type II 2008/03/19 Siemens Ltd. 2810 7533 SN080336 Abbott Clinical Chemistry Phenytoin (Model IE07-20) Health Canada 41000 Type II 2008/03/19 Abbott Laboratories Ltd. 2806 4021 SN080337 Siemens Dade Behring Complement Reagents (Model OWZD11; Lot# 542849) Health Canada 39678 Type II 2008/03/19 Siemens Ltd. 2810 7533 SN080338 Boston Scientific Advanced Bionics Clinician's Programmer Navigation V1.02 (Model P/N 9055528-001, SC-7150) Health Canada 40881 Type II 2008/03/19 Boston Scientific Hong Kong Ltd 2960 7128 SN080339 Draeger Medical Fabius GS (Model# 8604700) Health Canada 40720 Type II 2008/03/19 Draeger Medical Hong Kong Ltd. 2877 3077 SN080340 Beckman Coulter IMMAGE C-Reactive Protein CRP Reagent (Model # 447280) Health Canada 40898 Type II 2008/03/19 Beckman Coulter Hong Kong Ltd. 2240 6260 SN080341 VIASYS Microjack Patient Interface (Model # GP 320000-00) Health Canada 40966 Type II 2008/03/19 VIASYS Healthcare (Hong Kong) Ltd 6305 5575 SN080342 Cardinal Health Sterile Bowel Resection-Lithotomy Pack and Major Surgery Packs Health Canada 40924 Type II 2008/03/19 N/A N/A SN080343 Johnson & Johnson, Ortho-Clinical Blood Grouping Reagent AntiLe Bioclone (Model# 715280) Health Canada 38920 Type II 2008/03/19 Johnson & Johnson Medical Hong Kong 2738 2818 SN080344 Coopersurgical Mystic II Pump with M-Style Mushrooncup (Model no 10057) Health Canada 40725 Type II 2008/03/19 N/A N/A SN080345 Computerized Medical Systems Focal Workstation Health Canada 40151 Type II 2008/03/19 N/A N/A SN080346 Allez Spine Size 8 Pedicle Screws (Catalo # LG-PR0835, LGPR0840, LG-PR0845, LG-PR0850, LG-PR0855, LG-PR0880) FDA Z-0186-2008 to Z-0191-2008 Class II 2008/03/25 N/A N/A Medical Device Control Office 49 Department of Health The Government of HKSAR SN080347 GE Healthcare Mobile Fluoroscopy X-Ray System OEC Model 7600 AND 7700 FDA Z-0716-2008 to Z-0717-2008 Class II 2008/03/25 GE Medical Systems Hong Kong Ltd. 2783 1838 SN080348 Linemaster Wireless Footswitch Accessory (Model SP-9970214005112010 and SP-9970214-005112232) FDA Z-0933-2008 Class II 2008/03/25 N/A N/A SN080349 Smith & Nephew Exu-Dry Wound Burn Dressing FDA Z-1199-2008 to Z-1217-2008 Class II 2008/03/25 Smith & Nephew Healthcare Ltd. 2648 7700 SN080350 Stryker VertePort 10G Access Cannula w/Long Stylet System, 10G Cement Cannula, 10G Access Canula (short) and 11 G Cement Cannula FDA Z-1192-2008 to Z-1195-2008 Class II 2008/03/25 Stryker China Ltd 2518 6988 SN080351 Abbott CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators abd CELL-DYN 16 Controls (Part # 07H77-01) FDA Z-0455-2008 Class II 2008/03/25 Abbott Laboratories Ltd. 2806 4021 SN080352 ALN IVC Filter (Lot: 0107A, 0207A, 0207B, 0307A & 0407A) MHRA 2007/012/012/401/002 FSCA 2008/03/25 N/A N/A SN080353 GE Heatlhcare Advantx-E, Innova 2000, 2100IQ, 3100/3100IQ AND 4100/4100IQ MHRA 2008/002/026/061/016 FSCA 2008/03/26 Siemens Ltd. 2810 7533 SN080354 ASTRA PEP/RMT Products (Prodtuct Ref 71001, 71002, 71006, 71007, 71042 and 71052) MHRA 2008/002/027/291/003 FSCA 2008/03/26 N/A N/A SN080355 Jenx Bee Chair MHRA 2008/002/001/301/001 FSCA 2008/03/26 N/A N/A SN080356 AKW 2000 Series Seats MHRA 2007/009/017/601/005 FSCA 2008/03/26 N/A N/A SN080357 Olympus AU2700 Clinical Chemistry Analyser (Models : ALL; Serial: ALL) MHRA 2008/003/003/291/003 FSCA 2008/03/26 Olympus Hong Kong Ltd 2376 1805 SN080358 BIO-RAD ScanGel MHRA 2008/003/004/061/009 FSCA 2008/03/26 Bio-Rad Pacific Ltd. 2789 3300 SN080359 Sidhil Millennium Freedom Bed (Product Code(s) 1262, 1263, 1263/LOW) MHRA 2007/010/031/061/007 FSCA 2008/03/26 N/A N/A SN080360 Arcomedical 3100-J (FSB499) Burette Set (Batch N1068) MHRA 2008/003/012/291/012 FSCA 2008/03/26 N/A N/A SN080361 Trulife Heel & Elbow and the Heel & Ankle Gelbodies MHRA MDA/2008/013 MDA 2008/03/26 N/A N/A SN080362 Etac Patient Turner (Model 411973300) MHRA MDA/2008/018 MDA 2008/03/26 N/A N/A Medtronic International Ltd N/A Firm Initiated Field Action 2008/03/26 Medtronic International, Ltd. 2919 1300 Cryocath Technologies Inc. N/A Firm Initiated Field Action 2008/03/26 Cryocath Technologies Inc. N/A SN080363 Medtronic LIFEPAK 1000 SN080364 Cryocath FlexCath Steerable Sheath(Ref 3FC12) SN080365 American Medical Systems GreenLight HPS System (Part No. 0010-0070 and 0010-0075) FDA Z-0130-2008 Class II 2008/03/27 N/A N/A SN080366 Gambro cartridge blood set with Phoenix Hemodialysis System FDA Z-1367-2008 Class II 2008/03/27 Gambro China Ltd 2576 2688 SN080367 Draeger TI500 Isolette Infant Incubator (Catalog no.: MU20505), GT500 Globe Trotter Transport System (Catalog no.: MU20508) and Globe Trotter IC (Catalog no.: MU20509) FDA Z-1051-2008 to Z-1053-2008 Class II 2008/03/27 Draeger Medical Hong Kong Ltd. 2877 3077 SN080368 Smith & Nephew CALAXO Bioabsorbable Interference Screw FDA Z-0593-2008 to Z-061612008 Class II 2008/03/27 Smith & Nephew Healthcare Ltd. 2648 7700 Medical Device Control Office 50 Department of Health The Government of HKSAR SN080369 Siemens Magnetom Harmony Mobile MRI System, Magnetom Harmony syngo , Magenetom Symphony Magnetom Sonata syngo and Magnetom Symphony syngo FDA Z-1042-2008 to Z-1049-2008 Class II 2008/03/27 Siemens Ltd. 2810 7533 SN080370 Abbott Clinical Chemistry Creatine Kinase (Model LN 7D63-30) FDA Z-1109-2008 Class II 2008/03/27 Abbott Laboratories Ltd. 2806 4021 SN080371 Stryker Orthopaedics, UHR Universal Bipolar Component, Hip Prosthesis Component FDA Z-0621-208 to Z-0656-2008 Class II 2008/03/27 Stryker China Ltd 2518 6988 SN080372 Stryker Orthopaedics Locking Screw T7 (Catalog no 40-27622) FDA Z-1297-2008 Class II 2008/03/27 Stryker China Ltd 2518 6988 SN080373 Ventana Image Analysis Ssystem (VIAS) PATHWAY anti-HER2/neu (4B5) primary antibody with software version 2.3.0.2 (Model no. VIAS-799-10000-00) FDA Z-0571-2008 Class II 2008/03/27 N/A N/A SN080374 Bausch and Lomb Non-Sterile Multiple-use Phaco needles Bausch and Lomb N/A 2008/03/27 Baush and Lomb 2213 3371 Boston Scientific Hong Kong Ltd N/A 2008/03/27 Boston Scientific Hong Kong Ltd 2960 7128 Firm Initiated Field Action Firm Initiated Field Action SN080375 Boston Scientific COGNIS CRT-D device SN080376 Osypka Medical External Dual Chamber Pluse Generator PACE 203H MHRA 2008/002/022/401/004 FSCA 2008/03/28 N/A N/A SN080377 Volker Nursing Beds (Models 3010 and 5020) MHRA MDA/2008/020 MDA 2008/03/28 N/A N/A SN080378 Linet Hospital beds Eleganza Standard, Smart and Deluxe models MHRA MDA/2008/021 MDA 2008/03/28 N/A N/A SN080379 Smiths Medical CADD-MS 3 Ambulatory Infusion Pump (Model 7400, Recorder No 21-7401-54 and 21-7411-51) MHRA 2008/002/026/291/005 MDA 2008/03/28 Goodman Medical Supplies Ltd 2332 4455 SN080380 Philips Brilliance CT Systems Health Canada 39694 Type II 2008/03/31 Philips Electronics Hong Kong Ltd. 2876 7525 SN080381 Philips Carevue Chart Release C v C.00.00-06 and Intellivue Clinical Info Portfolio D Health Canada 41242 Type II 2008/03/31 Philips Electronics Hong Kong Ltd. 2876 7525 SN080382 Steris Tenzor Carbon Fiber Orthopedic Traction Health Canada 41089 Type II 2008/03/31 Swedish Trading Co., Ltd N/A SN080383 Steris C1160 Tray used with Steris System 1 Health Canada 41078 Type II 2008/03/31 Swedish Trading Co., Ltd N/A SN080384 Steris Amsco Remanufactured Prevacuum Sterilizers Health Canada 41256 Type II 2008/03/31 Swedish Trading Co., Ltd N/A SN080385 Smiths Medical Flo-2 kit With Mask Health Canada 41199 Type II 2008/03/31 N/A N/A SN080386 Radiometer Medical ABL80'S With Software Version 1.10 Health Canada 38880 Type II 2008/03/31 N/A N/A SN080387 International Technidyne Corp Avoximeter 1000E Oximeter Health Canada 41136 Type II 2008/03/31 N/A N/A SN080388 Maquet Jostra Heater-Cooler Unit 30 System Health Canada 41072 Type II 2008/03/31 Maquet Hong Kong Ltd N/A SN080389 Biosense Webster Navistar RMT Diagnostic/Ablation Catheter Health Canada 41193 Type II 2008/03/31 N/A N/A SN080390 Popper And Sons Perfektum Toomey Evacuating Syringe Health Canada 40097 Type II 2008/03/31 N/A N/A SN080391 Tomotherapy Hi-Art System Health Canada 41091 Type II 2008/03/31 TomoKnife (Hong Kong) Ltd 2609 0974 Medical Device Control Office 51 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -February 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SA080201 Organogenesis Apligraf, interactive wound and burn dressing (Lot # GS0711.20.01.2A and GS0711.22.01.2A) FDA Z-0675-2008 Class II 01-Feb-08 N/A N/A SA080202 Fertility Technology Resources Tucker Embryo Catheter and Morton IUI Catheter FDA Z-0662-2008 to Z-0667-2008 Class II 01-Feb-08 N/A N/A SA080203 Hoana LifeBed Patient Vigilance System (Model# 010135-01) FDA Z-0592-2008 Class II 01-Feb-08 N/A N/A SA080204 AADCO Rayshield Frame Mounted Overhead X-Ray Barrier FDA Z-0552-2008 Class II 01-Feb-08 N/A N/A VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7SA080205 100) FDA Z-0542-2008 to Z-0543-2008 Class II 01-Feb-08 N/A N/A SA080206 Ventana Benchmark, Benchmark XT, Benchmark LT, Discovery and Discovery XT Slide Staining System FDA Z-0537-2008 to Z-0541-2008 Class II 01-Feb-08 N/A N/A SA080207 Intuitive Surgical EndoWrist (Part # 400214-02, 400214-03, 420214-02 and 420214-03) FDA Z-0258-2008 Class II 01-Feb-08 N/A N/A FDA Z-0120-2008 Class II 01-Feb-08 N/A N/A SA080208 AmniSure ROM Test (Model # FMRT-1) SA080209 Biomet Straight Magnum Inserter Handle (REF# or Catalo # S313141) FDA Z-0115-2008 Class II 01-Feb-08 Goodman Medical Supplies Ltd 2332 4455 SA080210 Johnson and Johnson Depuy TK2 Compression Hip Screw Trauma Plate (REF 8315-35-004, 8315-35-104) FDA Z-0434-2008 to Z-0435-2008 Class II 01-Feb-08 Johnson & Johnson Medical Hong Kong 2738 2818 SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01) FDA Z-0551-2008 Class II 01-Feb-08 Abbott Laboratories Ltd. 2806 4021 SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20) FDA Z-0127-2008 Class II 01-Feb-08 Abbott Laboratories Ltd. 2806 4021 FDA Z-0529-2008 Class II 01-Feb-08 N/A N/A Health Canada 40047 Type II 04-Feb-08 Sanko Medical System (HK) Ltd 2384 0688 MHRA 2008/001/024/291/004 FSCA 04-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2008/001/024/601/003 FSCA 04-Feb-08 Abbott Laboratories Ltd. 2806 4021 MHRA 2008/001/014/291/020 FSCA 04-Feb-08 Stryker China Ltd 2518 6988 SA080213 Superior Oxy Serve II Oxygen Conserving Regulator (Model # MCRB-870-6) SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner Philips Brilliance Big Bore CT Scanners using software v2.2.1 SA080215 through v2.2.5 SA080216 Abbott AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0 (List # 3D54-08) SA080217 Stryker Burs SA080218 Siemens Urea Nitrogen (BUN) Flex reagent cartridge (DF21) (Lot no. FC8283 and FH8271) MHRA 2008/001/021/601/002 FSCA 04-Feb-08 Siemens Ltd. 2810 7533 SA080219 Roche COBAS AmpliPrep/ COBAS Taqman & High Pure System/COBAS Taqman 48 MHRA 2007/011/019/291/011 FSCA 04-Feb-08 Roche Diagnostics (Hong Kong) Limited 2485 7510 Medical Device Control Office 52 Department of Health The Government of HKSAR SA080220 Corin Cormet Head Trial Size 4/44 SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups MHRA 2008/001/023/291/002 FSCA Firm Initiated Field Action Firm Initiated Field Action 04-Feb-08 N/A N/A 04-Feb-08 Stryker China Ltd 2518 6988 06-Feb-08 CELKI Medical Company 2268 9258 Stryker China Ltd N/A CELKI Medical Company N/A Intuitive Surgical da Vinci S Surgical System 8mm instrument SA080223 cannula, 8mm Long instrument cannula and 5 mm instrument cannula (Part#:420002-01. 420004-01 and 420011-01) FDA Z-0657-2008 to Z-0659-2008 Class II 11-Feb-08 N/A N/A Intuitive Surgical da Vinci S Surgical System 5 mm instrument cannula (Part#:420011-01) FDA Z-0669-2008 Class II 11-Feb-08 N/A N/A Baxter RenalSoft v.2.0 Patient Management Software Suite - HD SA080225 Module and Baxter Renal Software Suite v3.0 and v3.1 - Renal Link HD Module FDA Z-0527-2008 to Z-0528-2008 Class II 11-Feb-08 Baxter Healthcare Ltd 2807 8555 Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6, 10 and 16 slice PET/CT Systems FDA Z-0461-2008 to Z-0462-2008 Class II 11-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 SA080227 Philips Page Writer Touch Cardiograph (Model # 860284) FDA Z-0124-2008 Class II 11-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ FDA Z-0690-2008 to Z-0692-2008 Class II 11-Feb-08 GE Medical Systems Hong Kong Ltd. 2783 1838 Blackstone Hallmark Anterior Cervical Plate System (REF#62SA080229 3140) FDA Z-0478-2008 Class II 11-Feb-08 N/A N/A SA080230 Biomet CC Cruciate Tibial Tray (Product no 141232, 141234) FDA Z-0706-2008 to Z-070-2008 Class II 11-Feb-08 N/A N/A SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518) FDA Z-0660-2008 Class II 11-Feb-08 N/A N/A SA080232 Molnycke Health Care Laparoscopic Cholecysectomy MHRA 2008/001/031/291/002 FSCA 12-Feb-08 N/A N/A SA080233 Schiller FRED Easy Defibrillator MHRA 2008/001/024/291/003 FSCA 12-Feb-08 Ultronics Enterprises Ltd 2764 5208 SA080234 Days Healthcare Viper & Viper Plus Powerchairs MHRA 2008/001/022/301/002 FSCA 13-Feb-08 N/A N/A SA080222 Respironics Esprit ventilators SA080224 SA080226 SA080235 Arkray Assure 3 Blood Glucose Test Strips (PRODUCT NO 555050) FDA Z-0699-2008 Class II 18-Feb-08 N/A N/A SA080236 Biomet Ringloc Instrumentation Impactor Plate (Ref/Part # 31400620 - 31-400623, 31-400626, 31-400628) FDA Z-0700-2008 to Z-0705-2008 Class II 18-Feb-08 Goodman Medical Supplies Ltd 2332 4455 SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1) FDA Z-0934-2008 Class II 18-Feb-08 N/A N/A SA080238 Horizon Cardiology Hemo Monitoring System FDA Z-0710-2008 Class II 18-Feb-08 N/A N/A FDA Z-0738-2008 Class II 18-Feb-08 Fresenius Medical Care Asia-Pacific Ltd. 2802 2900 SA080239 Fresenius Medical Care Optiflux 180NR Advanced Fresenius Polysulfone (Catalog no. 0500318E) SA080240 Cook THSCF-35-260-3-AUS2 SA080241 Medtronic Kyphon Functional Anesthetic Discography (F.A.D.) Catheter System (Catlog # D014, D01B) SA080242 Medtronic Cardioblate Gemini-s model 49260 SA080243 Siemens Dade Behring BEP III System Medical Device Control Office (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 FDA Z-0135-2008 Class II 18-Feb-08 FDA Z-0948-2008 to Z-0949-2008 Class II 18-Feb-08 Medtronic International, Ltd. 886-22183-6130 FDA Z-0727-2008 Class II 18-Feb-08 Medtronic International, Ltd. 886-22183-6130 MHRA 2008/002/005/061/014 FSCA 20-Feb-08 Siemens Ltd. 2810 7533 53 Department of Health The Government of HKSAR SA080244 Care & Independence Systems InChair Sling GE Healthcare InstaTrak 3500 Plus with the Cranial Application for SA080245 Image Guide Surgery GE Healthcare Clinical Information Centre (CIC) Pro v5.0.3 and SA080246 5.0.6 MHRA 2007/004/030/261/002 FSCA 20-Feb-08 N/A N/A MHRA 2008/002/011/061/008 FSCA 21-Feb-08 GE Medical Systems Hong Kong Ltd. 2783 1838 MHRA 2008/002/006/601/033 FSCA 21-Feb-08 GE Medical Systems Hong Kong Ltd. 2783 1838 SA080247 Abbott Comfort T-handle Hudson Connector with Impactor Cap (Part # 1006-1) FDA Z-0880-2008 Class II 22-Feb-08 Abbott Laboratories Ltd. 2806 4021 SA080248 Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System FDA Z-0677-2008 to Z-0687-2008 Class II 22-Feb-08 Siemens Ltd. 2810 7533 SA080249 Roche LIPC Lipase Colorimetric Reagent (Catalog No.: 03029590322) FDA Z-0688-2008 Class II 22-Feb-08 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA080250 Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2, v6.6 and v8.0 (Models : ALL) FDA Z-0718-2008 Class II 22-Feb-08 Varian Medical Systems Pacific Inc. 2724 2836 SA080251 Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24) (Product Code: 866.2500; Part No. 173400) FDA Z-0718-2008 Class II 22-Feb-08 N/A N/A SA080252 Rockwell Medical RenalPure Liquid Acid Concentrate R-006, R-235 and R-259 ; Glacial Acidic Acid and Dri-Sate Glacial Acidic Acid FDA Z-0871-2008 to Z-0875-2008 Class II 22-Feb-08 N/A N/A SA080253 ConMed Electrosurgical blades and Needles MHRA 2008/002/011/061/011 FSCA 22-Feb-08 N/A N/A SA080254 Unipath SmartCheck INR POC Meter and Consumables MHRA 2008/002/020/061/008 FSCA 22-Feb-08 N/A N/A SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX MHRA 2008/002/006/291/001 FSCA 22-Feb-08 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA080256 Philips General X-Ray System MHRA 2008/002/012/061/007 FSCA 22-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 SA080257 Philips X-Ray System Types Omni Diagnost Eleva MHRA 2008/002/013/061/004 FSCA 22-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 FDA N/A Press Release 26-Feb-08 N/A N/A MHRA 2008/002/012/061/008 FSCA 27-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2008/002/015/061/001 FSCA 27-Feb-08 Medtronic International, Ltd. 886-22183-6130 MHRA 2008/002/014/601/063 FSCA 27-Feb-08 N/A N/A Bausch and Lomb N/A Firm Initiated Field Action 27-Feb-08 Baush and Lomb 2213 3371 Baxter Heparin Sodium Injection multi-dose, single dose vials and SA080263 HEP-LOCK heparine flush products (lots: ALL) FDA N/A Press Release 29-Feb-08 Baxter Healthcare Ltd 2807 8555 Siemens Primus Linear Accelerator System and Mevatron Linear SA080264 Accelerator Systems FDA Z-0850-2008 to Z-0852-2008 Class II 29-Feb-08 Siemens Ltd. 2810 7533 FDA Z-0732-2008 Class II 29-Feb-08 Siemens Ltd. 2810 7533 FDA Z-0731-2008 Class II 29-Feb-08 Carestream Health Hong Kong Limited 2564 9759 MHRA MDA/2008/008 MDA 29-Feb-08 N/A N/A FDA Z-0581-2008 to Z-0584-2008 Class II 29-Feb-08 N/A N/A Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating SA080258 patch - (i) Back; (ii) Arm, Neck, and Leg SA080259 Philips Easy Diagnost Eleva family, Easy Diagnost Classic family and Diagnost 76 plus family SA080260 Medtronic Internal Defrillation Handles and Electrodes SA080261 Baxa Corporation EM4200 Exacta-Mix Compounder Operating Software V1.05, 1.06 & 1.06.1 SA080262 Bausch and Lomb Stellaris Vision Enhancement System Siemens Syngo Imaging System with VB30A version of software (Model No. 10014063) Kodak DirectView Model DR 3000 System, Stationary X-Ray SA080266 System Hill-Rom Avantguard 1200 and 1400 with manually operated lockSA080267 out function SA080265 SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B) Medical Device Control Office 54 Department of Health The Government of HKSAR Intuitive Surgical daVinci S Surgical System (Model No. IS2000) SA080269 and Surgical Endoscopic Instrument Control System (Model No IS2000) Intuitive Surgical daVinci S Surgical System, Endoscopic SA080270 Instrument Control System (Model No IS2000) with Isolation Transformer and Vision Cart (Model VS1000 and VS2000) FDA Z-0079-2008 Class II 29-Feb-08 Chindex 2892 0301 FDA Z-0151-2008 to Z-0152-2008 Class II 29-Feb-08 N/A N/A FDA Z-0724-2008 to Z-0726-2008 Class II 29-Feb-08 N/A N/A SA080272 Philips Digital Diagnost Family MHRA 2008/002/019/063/003 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 SA080273 Philips EasyVision RAD MHRA 2008/002/020/061/007 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No SA080274 1320-0231) MHRA 2008/002/006/061/001 FSCA 29-Feb-08 Stryker China Ltd 2518 6988 MHRA 2008/002/019/061/020 FSCA 29-Feb-08 Philips Electronics Hong Kong Ltd. 2876 7525 29-Feb-08 Johnson & Johnson Medical Hong Kong 2738 2818 SA080271 SA080275 Nova EZ CHEM Creatinine Meter, Control Solution and Linearity Solution Philips Digital Diagnost family, Bucky Diagnost family, Easy Diagnost family, Thoravision SA080276 Depuy polyethylene knee bearings Medical Device Control Office MHRA 2007/010/031/061/010 55 FSCA Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -January 2008 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No SA080101 Medtronic CD Horizon Agile Dynamic Stabilization Device MHRA 2007/011/013/061/020 FSCA 2008/01/02 Medtronic International, Ltd. 2919 1362 SA080102 Smiths Medical Graseby 500 and 505 volumetric infusion pumps (Models: ALL) MHRA MDA/2007/100 MDA 2008/01/02 Smiths Medical (S.E. Asia) Ltd. N/A SA080103 Medtronic Satellite Spinal System, Satellite Sphere CoCr, Satellite System Sphere PEEK and Material Stainless Steel/Radel FDA Z-0192-2008 to Z-0210-2008 Class II 2008/01/03 Medtronic International, Ltd. 2919 1362 SA080104 Roche Ammonia/Ethanol/CO2 Calibrator, Control N (Normal) and Control A (Abnormal) (Catalog no. 20751995190, 20752401190, 20753009190) FDA Z-0377-2008 to Z-0379-2008 Class II 2008/01/03 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA080105 Rita Medical Vortex VX Port System (REF/Part no.: P5455K; Catalog No.: P5455, Latex Free, Sterile) FDA Z-0149-2008 Class II 2008/01/03 N/A N/A SA080106 Ellex Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-Scan modality FDA Z-0148-2008 Class II 2008/01/03 N/A N/A FDA Z-0153-2008 to Z-0154-2008 Class II 2008/01/03 N/A N/A FDA Z-0456-2008 Class II 2008/01/03 N/A N/A FDA Z-0523-2008 to Z-0524-2008 Class II 2008/01/03 N/A N/A MHRA 2007/012/006/061/016 FSCA 2008/01/07 N/A N/A SA080107 SA080108 SA080109 SA080110 Precept Medical Products Tape Fog Shield Surgical Mask Green Fiberglass Free and Foam Fog Shield Surgical Mask Green Fiberglass Free (Reorder#65-3322 and 65-3320) Microbiologics P.vulgaris, DuoPacksI (Product Catalog # 0691P, ARCC 0427; Exp 2008-9) BatteryZone Life+cel (OEM P/N 9146-001 and 9141-001 ; Part # 7L877 and 2L561) Hill-Rom SM647 Medical Charis and SM608 Relaxation Chairs (Serial no HRP000698167 - HRP000733692) SA080111 Philips Digital Diagnost Family MHRA 2007/009/006/401/002 FSCA 2008/01/07 Philips Electronics Hong Kong Ltd. 2876 7525 SA080112 ThermoFisher Scientific DADE Cardiac TL Assayed Cardiac Marker Control MHRA 2007/012/018/051/002 FSCA 2008/01/07 N/A N/A SA080113 Horcher Lifting System Powered Patient Positioner MHRA 2007/007/010/401/004 FSCA 2008/01/07 N/A N/A SA080114 Select Healthcare DUO Transfer Slide Deluxe and Duo Transfer Slide (Model LOCO-400A and LOCO-410A) MHRA 2007/008/006/401/005 FSCA 2008/01/07 N/A N/A SA080115 Smiths Medical CADD Medication Cassette Reservoirs (Recorder No.: 21-7002-24, 21-7001-24, 21-7100-24) MHRA 2007/012/018/051/001 FSCA 2008/01/09 Goodman Medical Supplies Ltd 2332 4455 SA080116 ProTime Microcoagulation System PROTIMEINT MHRA 2007/011/028/291/005 FSCA 2008/01/09 N/A N/A SA080117 Stryker Distal Depth Screw Guage (Catalog. no. 12146000, LOT/BATCH NO:K532495) MHRA 2007/011/027/061/012 FSCA 2008/01/09 Stryker China Ltd 2518 6988 SA080118 Stryker Stretchers (Model No.: 660, 721, 735, 1001, 1002, 1005, 1015, 1020, 1069) MHRA 2007/012/013/061/010 FSCA 2008/01/09 Stryker China Ltd 2518 6988 N/A SA080119 SA080120 SA080121 SA080122 Fresenius Medical Care multiFiltrate acute dialysis system BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Sterile Convenience Paks bioMerieux, BacT/ALERT FA Culture Bottles (Lot no 1017685, 101793 and 1017788) Abbott CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes (List no 08H49-02) Medical Device Control Office 2007/012/017/051/003 FSCA 2008/01/09 Fresenius Medical Care Asia Pacific Ltd. BD N/A Firm Initiated Field Action 2008/01/09 BD 2575 8668 FDA Z-0457-2008 Class II 2008/01/11 Biomerieux (Hong Kong) 2356 7033 FDA Z-0301-2008 Class II 2008/01/11 Abbott Laboratories Ltd. 2806 4201 MHRA 56 Department of Health The Government of HKSAR SA080123 Siemens IMMULITE/IMMULITE 1000, IMMULITE 2000 and IMMULITE 2500 Operators MHRA 2008/001/004/601/001 FSCA 2008/01/14 Siemens Ltd. 2810 7533 SA080124 Siemens Syva Emit II Plus Amphetamines Assay (Catalog No 9C039ul, Lot Z10) MHRA 2008/001/003/601/002 FSCA 2008/01/14 Siemens Ltd. 2810 7533 SA080125 Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ; Lot # 20060605) MHRA 2007/012/020/061/001 FSCA 2008/01/14 Smith & Nephew Healthcare Ltd. SA080126 Fresenius Kabi Orchestra Base Primea MHRA 2008/001/007/061/010 FSCA 2008/01/14 N/A SA080127 AMO VISX STAR excimer laser chair MHRA 2008/001/004/061/010 FSCA 2008/01/14 THI Holdings Inc. SA080128 Stephan Neonatel Transport Ventilator MHRA 2007/012/007/061/002 FSCA 2008/01/15 N/A N/A SA080129 BD FACSDiva software v6.0 and 6.1 with the HP XW4400 Computer System MHRA 2008/001/008/061/012 FSCA 2008/01/15 BD 2575 8668 SA080130 Fannin GU Fibrillator Unit 3821 MHRA 2008/001/009/291/003 FSCA 2008/01/15 N/A N/A SA080131 Datascope CS 100 Intro-Aortic Balloon Pump and CS 300 IntraAortic Balloon Pump MHRA 2008/001/009/291/002 FSCA 2008/01/15 Datascope Corp Asia-Pacific 2647 9713 SA080132 Boston Scientific Stainless Steel Greenfield Vena Cava Filter Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128 SA080133 Boston Scientific Slimline 200 Micron Delivery System Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128 SA080134 Boston Scientific Galaxy 2 and ClearView Systems Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128 SA080135 Boston Scientific ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs Boston Scientific Hong Kong Ltd N/A Firm Initiated Field Action 2008/01/16 Boston Scientific Hong Kong Ltd 2960 7128 SA080136 Siemens Biograph 6, 16, 40-3 Ring, 40 TruePoint, 64-3 Ring and DUO LSO FDA Z-0247-2008 to Z-0252-2008 Class II 2008/01/16 Siemens Ltd. 2810 7533 SA080137 Johnson and Johnson CORDIS FireStar and Dura Star RX PTCA Dilatation Catheters Johnson & Johnson Medical Hong Kong N/A Firm Initiated Field Action 2008/01/16 Johnson & Johnson Medical Hong Kong 2738 2818 SA080138 Abbott ARCHITECT i System Assay CD-ROM-WW (List No. (LN) 6E59) FDA Z-0299-2008 Class II 2008/01/17 Abbott Laboratories Ltd. 2806 4021 SA080139 Ventena Medical System's Symphony Staining System, KPA (Model # : 2200000; catalog# 900-SYM1 and 900-SYM3) FDA Z-0300-2008 Class II 2008/01/17 N/A N/A SA080140 Toshiba Aplio XG Diagnostic Ultrasound System (Model: SSA-790A with version 1.1 software) FDA Z-0305-2008 Class II 2008/01/17 N/A N/A SA080141 Encore Medical VariLift Bone Plug w/ End Cup FDA Z-0306-2008 to Z-0311-2008 Class II 2008/01/17 N/A N/A SA080142 Siemens ACUSON Antares, Ultrasound System FDA Z-0297-2008 to Z-0298-2008 Class II 2008/01/17 Siemens Ltd. 2810 7533 SA080143 Oasis Medical PremierEdge MICROSURGICAL KNIFE FDA Z-0485-2008 to Z-0516-2008 Class II 2008/01/17 N/A N/A SA080144 Fisher and Paykel Healthcare Cosycot UPS MHRA 2007/005/010/401/004 FSCA 2008/01/17 Tokibo Co. (HK) Ltd. 2418 9698 SA080145 Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems MHRA 2008/001/003/291/003 FSCA 2008/01/17 Siemens Ltd. 2810 7533 SA080146 VacSax and GelSax Disposable Suction Liners MHRA 2007/011/023/401/002 FSCA 2008/01/17 Goodwin Health Care Ltd 2408 8838 SA080147 Baxter Healthcare Home Choice Automated PD System and Home Choice Pro Automated PD System Health Canada 39272 Type II 2008/01/18 Baxter Healthcare Ltd 2807 8555 SA080148 Baxter Healthcare Infusor 2mL/HR Health Canada 39388 Type II 2008/01/18 Baxter Healthcare Ltd 2807 8555 Medical Device Control Office 57 2645 8703 N/A Department of Health The Government of HKSAR SA080149 BD difco Shigella antiserum poly groupb Health Canada 39695 Type II 2008/01/18 BD 2575 8668 SA080150 BD vacutainer push button blood collection sets with pre-attached holder (Model# 367352, 368656) Health Canada 39405 Type II 2008/01/18 BD 2575 8668 SA080151 BD Calibrite APC Beads (Model # 340487) Health Canada 39352 Type II 2008/01/18 BD 2575 8668 SA080152 Philips Medical Allura XPER FD20 System (S/N 297) Health Canada 39575 Type II 2008/01/18 Philips Electronics Hong Kong Ltd. 2876 7525 SA080153 Philips Medical BV Endura and BV Pulsera (Model# MMC 2011, MMC 2011) Health Canada 39582 Type II 2008/01/18 Philips Electronics Hong Kong Ltd. 2876 7525 SA080154 Varian RPM Respiratory Gating System Health Canada 39358 Type II 2008/01/18 Varian Medical Systems Pacific Inc. 2724 2836 SA080155 Roche Diagnostics Coagucheck XS PT strips 2x24, 24,6 tests (Model#4625315017, 4625358017, 4625374190) Health Canada 39425 Type II 2008/01/18 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA080156 Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133, 133X) Health Canada 39423 Type II 2008/01/18 Bio-Rad Pacific Ltd. 2789 3300 SA080157 Cardinal Health Medley Pump Module (Model 8100LVP) Health Canada 39408 Type II 2008/01/18 N/A N/A SA080158 Henry Schien Mirror Defogger (Model# 1000459, 17-20902) Health Canada 39386 Type II 2008/01/18 N/A N/A SA080159 M.C. Healthcare Maxxum Hi/Lo Bed Health Canada 39652 Type II 2008/01/18 N/A N/A SA080160 BHM Medical 1000LB Scale, 300KG,Class 3 Scales, 800 LB Scale, Ergolift with Scale Health Canada 39427 Type II 2008/01/18 N/A N/A St. Jude Medical N/A Firm Initiated Field Action 2008/01/18 St. Jude Medical N/A SA080161 St. Jude Medical Epic, Atlas and Convert Family of ICDs SA080162 Smith & Nephew Universal Hip Extractors (Part No. 72200626) MHRA 2008/001/004/061/003 FSCA 2008/01/21 Smith & Nephew Ltd. N/A SA080163 Philips M3170 IntelliVue Patient Link running software versions J.00.23, J.00.24, J.00.25 and J.00.26 MHRA 2008/001/011/061/026 FSCA 2008/01/21 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2007/012/024/601/003 FSCA 2008/01/21 Abbott Laboratories Ltd. 2806 4021 FDA Z-0150-2008 Class II 2008/01/24 Datascope Corp Asia-Pacific 2647 9713 SA080164 SA080165 Abbott CELL-DYN 4000 and CELL-DYN Sapphire WBC Reagent (Part A, List # 01H77-01) Datascope Panorama Patient Monitoring Network, Panorma Telepack 608 SA080166 Sechrist Hyperbaric Chanmber Curney FDA Z-0733-2008 to Z-0737-2008 Class II 2008/01/24 N/A N/A SA080167 Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems MHRA 2008/001/017/291/012 FSCA 2008/01/24 Siemens Ltd. 2810 7533 SA080168 Alcon Ophthalmic Procedure Pack MHRA 2008/001/004/061/006 FSCA 2008/01/24 Alcon Hong Kong Ltd 2568 0636 SA080169 Wescor Osmocoll SS-025, SS-038 and SS-039 MHRA SA080170 Medtronic Synchromed EL, Synchromed II and IsoMed drug infusion pumps SA080171 SA080172 2008/001/017/291/013 FSCA 2008/01/24 N/A N/A Medtronic International Ltd N/A Firm Initiated Field Action 2008/01/24 Medtronic International, Ltd. 2891 4456 ev3 IntraStent Unmounted Balloon Expandable Stents MHRA 2008/001/011/291/003 FSCA 2008/01/28 Conmed Limited 2854 4413 Chattanooga Electrotherapy Devices (Intelect and Vectra Series) MHRA 2007/012/020/061/019 FSCA 2008/01/28 N/A N/A SA080173 Lombard Medical Aorfix Stent Grafts MHRA 2008/001/017/291/011 FSCA 2008/01/28 N/A N/A SA080174 Dixons Tudor Edwards Double Rib MHRA 2008/001/017/601/001 FSCA 2008/01/28 N/A N/A SA080175 Cyberonics VNS Therapy Lead Model 302 MHRA 2008/001/002/061/002 FSCA 2008/01/28 GM Medical N/A SA080176 BD FACS Sample Prep Assistant II instruments MHRA 2007/010/002/061/013 FSCA 2008/01/28 BD 2575 8668 Medical Device Control Office 58 Department of Health The Government of HKSAR SA080177 Stryker V40 Femoral Heads SA080178 Johnson and Johnson STERRAD Sterilizer System (50, 100S, 200 and NX Sterilizers) MHRA 2007/012/004/061/009 SA080179 Medtronic Model 8870 N'Vision Clinican Programmer Software Application Card MHRA SA080180 Biosite Triage Micro C. Difficile Panel (Catalog no 96000) SA080181 AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) Medical Device Control Office MHRA 2008/001/016/121/001 2008/01/30 Stryker China Ltd 2518 6988 FSCA 2008/01/30 Johnson & Johnson Medical Hong Kong 2738 2818 2008/001/003/291/014 FSCA 2008/01/30 Medtronic International, Ltd. 2891 4456 MHRA 2008/001/017/291/003 FSCA 2008/01/30 N/A N/A FDA N/A Class I/Press Release 2008/01/31 N/A N/A 59 FSCA Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts -December 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/12/03 Medtronic International, Ltd. 2919 1362 SA071201 Medtronic Bravo pH capsule with delivery system (Proudct Numbers 9012B1011 and 9012B1001) SA071202 Philips Brilliance or MX8000Dual v.EXP CT Couch MHRA 2007/010/029/061/017 FSCA 2007/12/04 Philips Electronics Hong Kong Ltd. 2876 7525 SA071203 Vital PET/CT Visualization option available in ViTALConnect Version 4.0 and 4.1 MHRA 2007/011/022/061/010 FSCA 2007/12/04 N/A N/A MHRA 2007/011/026/061/018 FSCA 2007/12/04 N/A N/A MHRA MDA/2007/090 MDA 2007/12/05 Draeger Medical Hong Kong Ltd. 2877 3077 SA071204 SA071205 SA071206 ZOLL LifeVest WCD3000 Battery Pack Draeger Medical Anaesthetic Gas Scaverging System (AGSS) receiver Procare Privac set (Product code 24760) MHRA MDA/2007/091 MDA 2007/12/05 N/A N/A SA071207 Stryker V40+ 16mm Offset Femoral Heads and associated Femoral Head Trails MHRA 2007/011/026/061/011 FSCA 2007/12/06 Stryker China Ltd 2518 6988 SA071208 Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System MHRA 2007/011/030/061/012 FSCA 2007/12/06 Baxter Healthcare Ltd 2807 8555 SA071209 Ohio Willow Wood Alpha Original Locking Liners (ALL-X0XX / ALLX1XX / ALL-X2XX) MHRA 2007/008/013/051/014 FSCA 2007/12/06 N/A N/A SA071210 Steering Developments Lifestyle JW1, JWII and JWX1 Wheelchair Power Assist System MHRA 2007/006/022/261/001 FSCA 2007/12/06 N/A N/A SA071211 VIASYS Infant Flow SiPAP Paediatric Respiratory Support Device MHRA MDA/2007/093 MDA 2007/12/07 Viasys Healthcare Hong Kong Ltd 2891 8730 SA071212 MI Tech Hanarostent Anti Reflux and Choostent MHRA 2007/008/014/061/009 FSCA 2007/12/07 N/A N/A SA071213 Sunrise Medical Little Gem 2 MHRA 2007/011/016/301/002 FSCA 2007/12/07 N/A N/A SA071214 Movingpeople.net Beatle Y.e.S. MHRA 2007/005/003/401/001 FSCA 2007/12/07 N/A N/A SA071215 Philips MD Eleva Flat Detector (Ref XDB087-070515/BW) MHRA 2007/011/030/061/010 FSCA 2007/12/07 Philips Electronics Hong Kong Ltd. 2876 7525 SA071216 Stryker UHR Universal Head Bipolar Component MHRA 2007/011/027/061/002 FSCA 2007/12/07 Stryker China Ltd 2518 6988 SA071217 Terumo Integrated Centrifugal System Control Unit (Model 801046, Lot: 0049, 0079) Health Canada 38444 Type II 2007/12/10 Terumo China (H.K.) Ltd. 2866 0811 SA071218 Terumo Ultrasonic Air Sensor (Model: 5773, 5785, 5791) Health Canada 39116 Type II 2007/12/10 Terumo China (H.K.) Ltd. 2866 0811 SA071219 Philips M3170 Intellivue Patient Link (Model: M3170, LOT: S/A 4721A01711) Health Canada 38975 Type II 2007/12/10 Philips Electronics Hong Kong Ltd. 2876 7525 SA071220 Smith & Nephew Genesis II femoral sets Health Canada 39055 Type II 2007/12/10 Smith & Nephew Ltd. 2648 7700 SA071221 Depuy PFC Sigma Knee System - ALL Polyethlen, PS RP Bearing, Stabilized TIBI and Preservation Unicondylar Knee -ALL POL Health Canada 38472 Type II 2007/12/10 DePuy Inc (J&J) Health Canada 38915 Type II 2007/12/10 Abbott Laboratories Ltd. 2806 4021 Health Canada 38840 Type II 2007/12/10 N/A N/A Health Canada 37977 Type II 2007/12/10 N/A N/A Health Canada 38921 Type II 2007/12/10 Sanko Medical System (HK) Ltd 2384 0688 FDA Z-0293-2008 Class II 2007/12/10 Sanko Medical System (HK) Ltd 2384 0688 SA071224 Abbott AxSYM Gentamicin and TDx/TDxFLx Gentamicin (Model 7A65-20 and 9512-60) Radiometer Pump tubes for ABL800 Series (Model: 842-326, 842327, 842-328, 902-754, 905-671) Sigma 8002 Dual Channel Infusion Pump (Model 35061) SA071225 Toshiba Asteion M/S4, Asteion S/S (Mode TSX-021A) SA071226 Toshiba-Interventional Angiography System, Infinix i (Model DFP8000D) SA071222 SA071223 Medical Device Control Office 60 2738 2894 Department of Health The Government of HKSAR SA071227 SA071228 SA071229 SA071230 SA071231 Medtronic 0-arm Imaging System (Product Code B1-700-00027) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T and 46 Code L (Cat no. 01.00211.154 and 01.00211.146) Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application (Model EX080801CD) Teleflex Pilling Center-Action Forceps with Insulated Shafts (Cat no. 505015, 505039 and 505045) Wright Medical Technology Odyssey Femoral Holder/Driver (Part no. K001-7410) FDA Z-0294-2008 Class II 2007/12/10 Medtronic International, Ltd. 2919 1362 FDA Z-0275-2008 to Z-0276-2008 Class II 2007/12/10 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 FDA Z-0179-2008 Class II 2007/12/10 N/A N/A FDA Z-0266-2008 to Z-0268-2008 Class II 2007/12/10 N/A N/A FDA Z-0290-2008 Class II 2007/12/10 Starry Medical Technology Ltd 2381 0279 SA071232 Xoran MiniCAT for ENT FDA Z-0296-2008 Class II 2007/12/10 N/A N/A SA071233 Oridion Capnostream20 Monitor with Nellcor Pulse Oximetry Module (Part no. CS08657) and Capnostream20 Monitor with Masiomor Pulse Oximetry Module (Part no. CS08659) FDA Z-0177-2008 to Z-0178-2008 Class II 2007/12/10 N/A N/A SA071234 Sunrise Medical Sapphire 2 and Sapphire LS 2 MHRA 2007/010/024/261/001 2007/010/009/261/001 FSCA 2007/12/11 N/A N/A SA071235 Philips Cardiac Viewer and Pulmonary Viewer Application MHRA 2007/011/030/061/009 FSCA 2007/12/12 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2007/011/022/601/005 FSCA 2007/12/14 N/A N/A MHRA 2007/010/001/291/003 FSCA 2007/12/14 Medisource MHRA 2007/011/008/291/006 FSCA 2007/12/14 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA071236 SA071237 Henry Schein EasyCam Eurolite, Eurolite II and Eurodoc Intra-oral Cameras ConMed Frazier and Poole Suction Intruments (Cat no. 0031030, 0033080, 0033120, 0031100, 0031070, 0033180, 0031050, 0033110, 0035040, 0033100) SA071238 Roche Elecsys HBsAgII and Elecsys Anti-HBs SA071239 Siemens Mevatron M2/PRIMUS Plus, Oncor Impresson Plus. Oncor Impression, ONCOR Avante Garde, Mevatron M2 Primus FDA Z-0380-2008 to Z-0384-2008 Class II 2007/12/14 Siemens Ltd. 2810 7533 SA071240 Biomet Orthopedics Vanguard PS Open Femoral (Ref. no.: 183130; Lot no. 395450) FDA Z-0123-2008 Class II 2007/12/14 Goodman Medical Supplies Ltd 2332 4455 SA071241 Straumann Palatal Implant (Article No. 042.335S and 042.336S) Frenius Kabi Applix Smart pump (all models) N/A Fresenius Medical Care Asia Pacific Ltd. N/A SA071242 SA071243 SA071244 SA071245 SA071246 SA071247 SA071248 SA071249 CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 2856-7, 3173-7, 3226-7, 33437, 3344-7, 3345-7, 3346-7, 3347-7, 3397-7, 3398-7) Sysmex SF-3000 Haematology Analyser, software version 00-01 on CPSU-4 sampler Radiometer Medical ABL77 Cal Packs Stryker Hipstar V40 Femoral Stem-127 degrees (Cat. No. 7850-5001 - 7850-5-012) Stryker Hipstar TMZF Cementless Hip Stem Protocol (Product no. LSP60) Stryker Triathlon MIS AP Sizer Body-left and Right, Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture Stryker inTouch Critical Care bed (Model 2130) and Stryker inTouch Zoom Critical Care bed (Model 2140) FDA Z-0277-2008 to Z-0278-2008 Class II 2007/12/14 MHRA MDA/2007/098 MDA 2007/12/18 MHRA 2007/012/005/061/022 FSCA 2007/12/19 N/A N/A MHRA 2007/011/005/401/011 FSCA 2007/12/19 N/A N/A MHRA 2007/009/003/061/009 FSCA 2007/12/19 N/A N/A FDA Z-0463-2008 to Z-0474-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988 FDA Z-0475-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988 FDA Z-0448-2008 to Z-0450-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988 FDA Z-0356-2008 to Z-0357-2008 Class II 2007/12/20 Stryker China Ltd 2518 6988 SA071250 B. Braun Excia Cemented Hip Stems (Size 9mm to 18mm) FDA Z-0436-2008 to Z-0445-2008 Class II 2007/12/20 B. Braun Medical (Hong Kong) Ltd. 2277 6125 SA071251 Abbott ARCHITECT c8000 Processing Module (List no 106-01) and ARCHITECT c16000 Processing Module (List no 3L77-01) FDA Z-0146-208 to Z-0147-2008 Class II 2007/12/20 Abbott Laboratories Ltd. 2806 4021 Medical Device Control Office 61 Department of Health The Government of HKSAR SA071252 SA071253 Roche Diagnostics LightCycler Capillaries (100uL) (Catalog # 03337090001, 04391039001, 03603946001, 03531414201) ConMed Accessory Electrode, Universal Electrodes and Ultra Clean Accessory Electrode FDA Z-0459-2008 Class II 2007/12/20 Roche Diagnostics (Hong Kong) Limited 2485 7510 FDA Z-0452-2008 Class II 2007/12/20 N/A N/A SA071254 BD Visitec Nucleus Hydrodissector (Catalog # 585155, 585793) FDA Z-0453-2008 to Z-0454-2008 Class II 2007/12/20 BD 2575 8668 SA071255 Accuray Multiplan Treatment Planning Software FDA Z-0364-2008 Class II 2007/12/20 Accuray Asia Ltd 2247 8688 SA071256 Cardinal Health Alaris Pump modules, model 8100 (Medley Pump modules) FDA Z-0460-2008 Class I 2007/12/20 N/A N/A SA071257 Axya Bone Anchor FDA Z-0331-2008 to Z- 0355-2008 Class II 2007/12/21 N/A N/A SA071258 Mizuho OSI Allegro 6800 Imaging Table (Operating) and OSI ProFx Operating Room Table 6850 FDA Z-0241-2008 to Z-0242-2008 Class II 2007/12/21 N/A N/A SA071259 VNUS ClosureFAST catheters (Model no. CL7-7-100) FDA Z-0132-2008 Class II 2007/12/21 N/A N/A FDA Z-0316-2008 to Z-0317-2008 Class II 2007/12/21 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 FDA Z-0363-2008 Class II 2007/12/21 N/A N/A FDA Z-0359-2008 Class II 2007/12/21 N/A N/A SA071260 SA071261 SA071262 Zimmer Minimally Invasive Solutions Technology Offset Rasp Handles (REF/Catalog# 7712-35-01 and 7712-35-02) Blackstone Medical Ascent POCTS (Posterior Occipital Cervical Thoracic System) ACIST Multi-Use Syringe Kit (Model A2000; SKU# 014612, Catalog#800061-003) SA071263 VKS Tibial Trial, Right/Left, Prep Guide FDA Z-0362-2008 Class II 2007/12/21 N/A N/A SA071264 Haemonetics cardioPAT System (Product list no 02050) FDA Z-0358-2008 Class II 2007/12/21 Haemonetics (Hong Kong) Limited 2868 9218 SA071265 Single Use Surgical Tibbs cannula - S044 all batches MHRA 2007/011/028/601/002 FSCA 2007/12/21 N/A N/A SA071266 Liko Sabina II 350-slingbar (prod no. 2027002) MHRA 2007/011/021/291/001 FSCA 2007/12/21 N/A N/A SA071267 Baxter Infusor 2ml/hr with Tubing Flow Restrictor (Product Code: 2C1071KJP) MHRA 2007/012/010/061/003 FSCA 2007/12/21 Baxter Healthcare Ltd 2807 8555 SA071268 OPTI LION E-Plus Cassettes(Model: BP7507) MHRA 2007/011/026/061/019 FSCA 2007/12/21 N/A N/A 2007/12/21 Cyberonics 2007/12/21 Terumo China (H.K.) Ltd. 2866 0811 SA071269 Cyberonics VNS Therapy Lead (Model 302) SA071270 Terumo Artifical vascular graft - Triplex SA071271 Bayer Contour TS blood glucose test strips SA071272 SA071273 SA071274 SA071275 Firm Initiated Field Action Firm Initiated Field Action Cyberonics N/A Terumo China (H.K.) Ltd. N/A FDA Press Release N/A 2007/12/21 Bayer Healthcare Ltd. (Hong Kong) 2814 7337 Toshiba Aquilion 32 and Aquilion 64 Health Canada 39250 Type II 2007/12/31 Sanko Medical System (HK) Ltd 2384 0688 TD-Synergy Software (TD-SYN-01) Health Canada 39374 Type II 2007/12/31 N/A N/A Health Canada 39288 Type II 2007/12/31 Beckman Coulter Hong Kong Ltd. 2814 0481 2814 0481 Instrumentation Laboratory HemosIL RecombiPlasTin and Hemoliance RecombiPlasTin Beckman Coulter Cytomics FC 500 Flow Cytometer and Cytomics FC 500 MPL Health Canada 39286 Type II 2007/12/31 Beckman Coulter Hong Kong Ltd. SA071276 Beckman Coulter Cytomics FC 500 Flow Cytometer Health Canada 37157 Type II 2007/12/31 Beckman Coulter Hong Kong Ltd. 2814 0481 SA071277 Beckman Coulter Sychron CX Systems salicylate reagent Health Canada 39284 Type II 2007/12/31 Beckman Coulter Hong Kong Ltd. 2814 0481 SA071278 Freedom Designs TriPod w/Anti tipper Manual Wheelchair (Model no.: TriPod, Tripod LT and TriPod Pediatric LT with Trailing AntiTipper-Caster- Axle Link) FDA Z-0137-2008 Class II 2007/12/31 N/A N/A Medical Device Control Office 62 Department of Health The Government of HKSAR SA071279 Medtronic Prestige Cervical Disc System, Implant Trial (REF/Catalog#: 6972226, 6972246, 6972266, 6972247, 6972267, 6972287) FDA Z-0138-2008 to Z-0143-2008 Class II 2007/12/31 Medtronic International, Ltd. 2919 1362 SA071280 Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test (Catalog.: 2820B and Batch no.: 531379) FDA Z-0145-2008 Class II 2007/12/31 N/A N/A FDA Z-0184-2008 to Z-0185-2008 Class II 2007/12/31 N/A N/A FDA Z-0286-2008 to Z-0287-2008 Class II 2007/12/31 N/A N/A FDA Z-0136-2008 Class II 2007/12/31 N/A N/A SA071284 Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 50800-036 and 508-00-040) Ellex Solitarie Opthalmic Laser System (Model no : LP4532-DGS P/N303896; Solitaire-SGS P/N 3038960) and Ellex Integre Duo (Model no. LP1RG-S P/N 3040000) OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs and Screw Systems, Distal Screw and Distal Peg Sultan Brand Mirror Defogger Health Canada 39364 Type II 2007/12/31 N/A N/A SA071285 Hudson Action forceps with insulated shafts Health Canada 38922 Type II 2007/12/31 N/A N/A SA071286 Span-America Medical Systems Pressureguard Easy Air Mattress Health Canada 39236 Type II 2007/12/31 N/A N/A SA071281 SA071282 SA071283 Medical Device Control Office 63 Department of Health The Government of HKSAR Month *Note: FDA F d Ref. d MDCO Description of Product No. Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No Smith & Nephew Ltd. 2648 7700 SA071101 Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup FDA Z-0017-2008 to Z-0033-2008 Class II 2007/11/01 SA071102 Remington Medical Disposable Urinary Leg Bags (Order no. 500-D and 1000-D) FDA Z-0058-2008 Class II 2007/11/01 N/A N/A SA071103 Philips Heartstart XL Monitor/Defibrillator (Model : M4735A) FDA Z-0062-2008 Class II 2007/11/01 Philips Electronics Hong Kong Ltd. 2876 7525 SA071104 SA071105 BD Microkeratome K3000 and K4000 (Cat No. 378660) Steris QFC1728 and QFC1729 Quick Connects Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back acetabular shell FDA FDA Z-0062-2008 Z-0101-2008 Class II Class II 2007/11/01 2007/11/01 BD 2575 8668 FDA Z-0072-2008 to Z-0073-2008 Class II 2007/11/01 Stryker China Ltd 2518 6988 SA071107 SA071106 Integra Flat Foot Implant KALIX II (Ref141 0xx) MHRA 2007/008/010/061/008 FSCA 2007/11/02 N/A N/A SA071108 Innovacon Strep A Rapid Test Strip and Strep A Rapid Test Device MHRA 2007/007/019/291/002 FSCA 2007/11/02 N/A N/A SA071109 Welch Allyn AED10 Automatic External Defibrillators FDA N/A Class I 2007/11/05 Umedco 2765 8222 SA071110 Beckman Coulter FC500 Flow Cytometry Systems with CXP Acquisition Software and FC500 MPL Cytometry Systems with MXP Acquisition Software MHRA 2007/010/026/601/002 FSCA 2007/11/07 Beckman Coulter Hong Kong Ltd. 2240 6260 SA071111 Boston Scientific RepliformR Tissue Regenration Matrix Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/07 Boston Scientific (HK) Ltd 2960 7128 SA071112 Bio-logic System Corp - Telescoping Camera Pole Assembly (part no 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580PNCART, model 580-VIDPOL) FDA Z-0001-2008 Class II 2007/11/08 Schmidt BioMed Tech (HK) Ltd 2620 8320 SA071113 Thoratec Implantable Ventricular Assist Devices (Catalogue No.: 10012-2555-001) Thoratec Corporation N/A Firm Initiated Field Action 2007/11/08 N/A N/A SA071114 Roche High Pure System (Product Numbers 03502295001 and 03702995001) MHRA 2007/010/029/061/009 FSCA 2007/11/09 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA071115 GE Healthcare Flexi-DT Mobile Radiographic Table MHRA 2007/010/025/061/006 FSCA 2007/11/09 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071116 Unomedical umbilical cord clamp clipper (Ref: 84006182) MHRA 2007/010/003/291/012 FSCA 2007/11/09 N/A N/A SA071117 Vernon-Carus Products containing 10x10 16ply X-Ray Detectable Swabs (49335) MHRA 2007/010/023/601/003 FSCA 2007/11/09 N/A N/A SA071118 Terumo Advanced Perfusion System 1 (Model no. 801046, Lot: 0049 AND 0079) Health Canada 38444 Type II 2007/11/12 Terumo China (H.K.) Ltd. 2866 0811 SA071119 Toshiba Aplio XG (SSA-790A) Health Canada 38432 Type II 2007/11/12 Sanko Medical System (HK) Ltd 2384 0688 SA071120 Baxter Healthcare Duoject EASY-Prep System Health Canada 38628 Type II 2007/11/12 Baxter Healthcare Ltd 2807 8517 SA071121 Abbott Aeroset System-Creatine Kinase Assay (Model 7D63-30) Health Canada 38476 Type II 2007/11/12 Abbott Laboratories Ltd. 2806 4021 SA071122 Abbott Accelerator APS System Input/Output Module (IOM) (Model: 7L01-01) Health Canada 38529 Type II 2007/11/12 Abbott Laboratories Ltd. 2806 4021 SA071123 Siemens Mevatron Linear Accelerators, Oncor Expression Digital Linear Accelerator and Oncor Care Systems Health Canada 34805 Type II 2007/11/12 Siemens Ltd. 2810 7533 SA071124 Siemens Mevatron Linear Accelerators and Oncor Impression Health Canada 38601 Type II 2007/11/12 Siemens Ltd. 2810 7533 SA071125 Beckman Coulter Immunoassay Analyzers Health Canada 38546 Type II 2007/11/12 Beckman Coulter Hong Kong Ltd. 2240 6260 Medical Device Control Office 64 Department of Health The Government of HKSAR SA071126 Remel Wellcogen N Meningitidis B/E Coli K Health Canada 37147 Type II 2007/11/12 Wenline Company 2521 2439 SA071127 Respironics Various Devices and Accessories Health Canada 38678 Type II 2007/11/12 Celki Medical Company 2332 3366 SA071128 Medtronic Sofamor Danek METRx System Bayonet Electrosurgical Pencil (REF (P/N) 9560575) FDA Z-0114-2008 Class II 2007/11/19 Medtronic International, Ltd. 2919 1362 SA071129 Philips Brilliance CT Big Bore (Model No. 728243) FDA Z-0121-2008 Class II 2007/11/19 Philips Electronics Hong Kong Ltd. 2876 7525 SA071130 GE Voluson E8 ultrasound scanner (version 6.2.0 and 6.2.1) FDA Z-0113-2008 Class II 2007/11/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071131 Siemens Medical charge-particle radiation therapy system (Mevatron, Oncor and Primus) FDA Z-0155-2008 to Z-0169-2008 Class II 2007/11/19 Siemens Ltd. 2810 7533 SA071132 GE Signa MFO/I Magnetic Resonance System FDA Z-0170-2008 Class II 2007/11/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071133 GE Sunisa Flexi-DT S0014115 Digital Table Flexi-DT FDA Z-0075-2008 Class II 2007/11/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071134 Abbott AxSYM Digoxin III Reagent Pack (List 6L07-20) Smiths Medical Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit (Sterile Ref: 536090) FDA Z-0064-2008 Class II 2007/11/19 Abbott Laboratories Ltd. 2806 4021 FDA Z-0100-2008 Class II 2007/11/19 Smiths Medical (S.E. Asia) Ltd. 2648 7700 SA071135 SA071136 Encore Medical Foundation Hip System Bipolar Modular FDA Z-0082-2008 to Z-0099-2008 Class II 2007/11/19 N/A N/A SA071137 Cardinal Health Texium Closed Male Luer (CML) (Model No.: 10012241) FDA Z-0218-2008 Class II 2007/11/19 N/A N/A SA071138 Varian Ximatron Digital Imaging (Ximavision) FDA Z-0213-2008 Class II 2007/11/19 Varian Medical Systems Pacific Inc. 2724 2836 SA071139 Karl Storz Fluid Management Stand (Product No. 26601EQ-KT) FDA Z-0144-2008 Class II 2007/11/19 Karl Storz Endoscopy China Ltd 2865 2411 SA071140 B Braun FT420T and FT430T CASPAR MHRA 2007/011/066/291/003 FSCA 2007/11/20 B. Braun Medical (HK) Ltd 2277 6611 SA071141 APC Medical Bedside Temporary Cardiac Pacemaker (Model 4170) MHRA 2007/006/005/401/014 FSCA 2007/11/20 N/A N/A SA071142 P3 Medical Robertshaw Endobronchial tubes (Rubber, Disposable) MHRA 2007/010/030/601/002 FSCA 2007/11/20 N/A N/A SA071143 Respironics Esprit Ventilator MHRA 2007/077/077/291/004 FSCA 2007/11/20 Celki Medical Company 2268 9258 SA071144 Olympus KeyMed BML-V232QR-26, BML-V232QR-30, BMLV242QR-30 and BML201Q MHRA 2007/009/025/601/002 FSCA 2007/11/22 Olympus Hong Kong Ltd 2376 1805 MHRA 2007/008/008/301/001 FSCA 2007/11/22 N/A N/A MHRA SA071145 SA071146 Pride Mobility Quantum 6000, 6000Z, 600, R-4000 and 1420, Pride LX Power wheelchair DiaSorin LIAISON Toxo IgM (Cat no 310710, lot no: 035052, 035052/1, 035052/2) 2007/009/027/601/003 FSCA 2007/11/22 N/A N/A N/A Firm Initiated Field Action 2007/11/26 Boston Scientific (HK) Ltd 2960 7128 SA071147 Boston Scientific LeVeen SuperSlim Needle Electrodes Boston Scientific(HK) Ltd SA071148 Boston Scientific Impulse Angiographic Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/26 Boston Scientific (HK) Ltd 2960 7128 SA071149 Ethicon Endopath 5mm Curved Dissector with Monopolar Cautery (Product Code: 5DCD, Lot no. D4HZ9Y) MHRA 2007/011/014/291/006 FSCA 2007/11/26 Johnson & Johnson Medical Hong Kong 2738 2818 SA071150 Invacare Typhoon Power Wheelchairs MHRA 2007/004/020/261/001 FSCA 2007/11/26 N/A N/A SA071151 Bio-Rad Variant II Turbo Hemoglobin Testing System MHRA 2007/011/014/061/010 FSCA 2007/11/26 Bio-Rad Pacific Ltd. 2789 3300 SA071152 Kavo Estertica E80 Treatment Unit MHRA 2007/011/013/061/011 FSCA 2007/11/26 N/A N/A SA071153 GE AW 4.2, AW Volumeshare and AW Volumeshare 2 Health Canada 38214 Type I 2007/11/27 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071154 BD BBL Fluid Thioglycollate Medium and BBL Trypticase Soy Broth (Model no 299108 and 299107) Health Canada 38700 Type II 2007/11/27 BD 2575 8668 Medical Device Control Office 65 Department of Health The Government of HKSAR SA071155 SA071156 SA071157 GE Definium 8000 Table and Revolution XR/d Table Abbott i-STAT Cartridges Philips Intellivue Patient Monitor System - Multi Measurement Server (Model no. M3001A) Health Canada Health Canada 36689 38822 Type II Type II 2007/11/27 2007/11/27 GE Medical Systems Hong Kong Ltd. Abbott Laboratories Ltd. 2783 1838 2806 4021 Health Canada 32105 Type II 2007/11/27 Philips Electronics Hong Kong Ltd. 2876 7525 SA071158 Medline Septoplasty Pack (Lot # 07CD1090 and 07DD3113) Health Canada 38314 Type II 2007/11/27 N/A N/A SA071159 Zimmer Trilogy Cluster Hole Shell, Non Coated (Model 620006022, lot 26208600) Health Canada 38744 Type II 2007/11/27 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SA071160 Bard Atlas PTA Balloon Dilation Catheter (Model AT-120124, Lot GFRF1789) Health Canada 38941 Type II 2007/11/27 N/A N/A SA071161 Patterson Dental Mirror Defogger / Solution (Lot 25622) Health Canada 38884 Type I 2007/11/27 N/A N/A Health Canada 38502 Type II FDA Z-0240-2008 Class II 2007/11/27 N/A N/A FDA Z-0183-2007 Class II 2007/11/27 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071162 Hill-Rom Versacare Hospital Beds (model P3200 and P3201) SA071163 GE OEC Insta Trak 3500 Plus with the Cranial Application SA071164 GE OEC Insta Trak 3500 Plus Fluoro Trak and Fluoro CAT Spinal Applications FDA Z-0181-2007 Class II 2007/11/27 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071165 Stryker wheeled stretcher (various models) FDA Z-0219-2008 to Z-0239-2008 Class II 2007/11/27 Stryker China Ltd 2518 6988 SA071166 Stryker T2 Locking Screw (Cat no 1896-5070S) FDA Z-0214-2008 Class II 2007/11/27 Stryker China Ltd 2518 6988 SA071167 Clarisonic Skin care system FDA Z-0182-2008 Class II 2007/11/27 N/A N/A SA071168 Coloplast Elefant Suction- Irriagtion Device ASP1 MHRA 2007/011/013/061/021 FSCA 2007/11/28 Coloplast (Hong Kong) Ltd N/A SA071169 Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator (List no 1E66-03 & 1E66-04) FDA Z-0288-2008 Class II 2007/11/29 Abbott Laboratories Ltd. 2806 4021 SA071170 B. Braun Vena Tech LP Vena Cava Filter System (Item no/REF 05010024, Model no 40DLP) FDA Z-0264-2008 Class II 2007/11/29 B. Braun Medical (Hong Kong) Ltd. 2277 6162 FDA Z-0255-2008 Class II 2007/11/29 Goodman Medical Supplies Ltd 2332 4455 FDA Z-0263-2008 Class II 2007/11/29 Baxter Healthcare Ltd 2807 8517 FDA Z-0289-2008 Class II 2007/11/29 N/A N/A Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/30 Boston Scientific (HK) Ltd 2960 7117 MHRA 2007/008/009/061/014 FSCA 2007/11/30 N/A N/A MHRA 2007/011/029/291/001 FSCA 2007/11/30 Smith & Nephew Ltd. 2648 7700 SA071171 SA071172 SA071173 SA071174 SA071175 SA071176 Biomet Interlok 67mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy (Product ref 141232) Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO (Product codes: 1500949 - 1500952) Metrika A1CNOW+ Sampler 10-Test Kits (Product no.: 3022) Boston Scientific PATHWAY Balloon Expandable Ureteral Access Sheath CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 3399-7, 3400-7, 3401-7, 34027, 3403-7, 3404-7, 3405-7) Smith & Nephew Femoral and Tibial Components of TC Plus, VKS and RT Plus Knee Implants Medical Device Control Office 66 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - October 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information* Boston Scientific(HK) Ltd Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No N/A Firm Initiated Field Action 2007/10/02 Boston Scientific (HK) Ltd 2960 7128 SA071001 Boston Scientific Advanced Bionics Electrode Insertion Tool for HiRes 90KR with HiFocus HelixR Electrode SA071002 Cardinal Health Procedure Pack MHRA 2007/008/024/061/003 FSCA 2007/10/02 N/A N/A SA071003 CODAN PVB (Product Code STP 85, Lot No. 700265 & 700995) MHRA 2007/009/003/051/002 FSCA 2007/10/02 N/A N/A SA071004 Pride Mobility Power Chairs 2005/011/016/301/004 N/A N/A Varian Acuity radiation therapy simulation systems FSCA Firm Initiated Field Action 2007/10/03 SA071005 MHRA Varian Medical Systems Pacific Inc. 2007/10/03 Varian Medical Systems Pacific Inc. 2724 2836 SA071006 Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy Compounding System SA071007 GE Healthcare OEC9900, OEC9800 and OEC8800 SA071008 Philips Gemini 16, Gemini GXL, Precedence and Brilliance SA071009 SA071010 SA071011 SA071012 SA071013 SA071014 SA071015 Philips Bucky, Digital and Easy Diagnost X-Ray System & Easy, Omni and Multi Diagnost Eleva Philips Pinnacle3 Radiation Therapy Planning (RTP) System and its associated Software Intuitive brand Da Vinci Surgical System (Model No. IS2000, Part no. 351040-04) Intuitive brand Da Vinci Surgical System Endoscopic Instrument Control System (Model IS1200, A4.3 SW Level) GE Innova 2100-IQ Digital Fluoroscopic Imaging System Cerner Millennium RadNet Auto Launch Study and Auto Launch Report Software functionalilites Davol Salute Fixation Reusable Handle, Fixation Reusable Shaft, Laparoscopic Sterile Implant Cartridge and Short Sterile Implant Cartridge CP-2007-001 FDA Z-1238-2007 Class I 2007/10/04 Jaspo Limited 2713 0007 MHRA 2007/008/029/291/017 FSCA 2007/10/04 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-0013-2007 to Z-0014-2007 Class II 2007/10/04 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-0907-2007 to Z-0912-2007 Class II 2007/10/04 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-1212-2007 Class II 2007/10/04 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-1245-2007 Class II 2007/10/04 N/A N/A FDA Z-1244-2007 Class II 2007/10/04 N/A N/A FDA Z-1088-2007 Class II 2007/10/04 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1243-2007 Class II 2007/10/04 N/A N/A FDA Z-1266-2007 to Z-1273-2007 Class II 2007/10/04 N/A N/A SA071016 Cardinal Health Pyxis Anesthesia System 3500 (Model 3500) FDA Z-0555-2007 Class II 2007/10/04 N/A N/A SA071017 Stryker Trident PSL Acetabular Shell FDA Z-1261-2007 Class II 2007/10/04 Stryker China Ltd 2518 6988 SA071018 Hitachi Medical Altaire Shoulder Coil FDA Z-1263-2007 Class II 2007/10/04 N/A N/A SA071019 DeRoyal Assorted sterile surgical kits/trays FDA Z-1205-2007 Class II 2007/10/04 N/A N/A SA071020 FDA Z-1228-2007 Class II 2007/10/04 N/A N/A FDA Z-1216-2007 to Z-1218-2007 Class II 2007/10/04 N/A N/A SA071022 NxStage Cartridge Express (CAR-170) Summit LX125 Swivel Collimator (Model D800), LX125V Swivel Collimator (Model E600) and PCS125 Swivel Collimator (Model F100) Merit Medical Surgical Convenience Kits, Custom and SPPT FDA Z-1262-2007 Class II 2007/10/04 N/A N/A SA071023 BD Neisseria Meningitidis Antisera Group Y Health Canada 37610 Type II 2007/10/04 BD 2575 8668 SA071024 Siemens Biograph Duo LSO, Biograph 6 and Biograph 16 Health Canada 37227 Type II 2007/10/04 Siemens Ltd. 2810 7533 SA071025 Boots Blood Glucose Monitoring System (50-53-811) MHRA 2007/008/030/291/007 FSCA 2007/10/05 N/A N/A SA071026 GE Flexi-DT Mobile Radiographic Table MHRA 2006/008/017/601/229 FSCA 2007/10/05 GE Medical Systems Hong Kong Ltd. 2783 1838 SA071027 Otto Bock Standard Kimba Spring (Ref TS8423) MHRA Boston Scientific(HK) Ltd Boston Scientific(HK) Ltd 2007/004/010/301/001 FSCA Firm Initiated Field Action Firm Initiated Field Action 2007/10/08 Otto Bock Asia Pacific Limited 2598 9772 2007/10/10 Boston Scientific (HK) Ltd 2960 7128 2007/10/10 Boston Scientific (HK) Ltd 2960 7128 SA071021 SA071028 Boston Scientific Transend EX Standard 0.014" Guidewire SA071029 Boston Scientific Advanced Bionics PrecisionR Implantable Pulse Generator -UPNM365SC11100 Medical Device Control Office N/A N/A 67 Department of Health The Government of HKSAR SA071030 Varian RTP Exchange software (interface application that supports the electronic transfer of radiation treatment planning data) SA071031 GE Disposable Multi Absorber Canister Varian Medical Systems Pacific Inc. CP-2007-093 Firm Initiated Field Action 2007/10/10 FDA Z-0006-2008 Class II Varian Medical Systems Pacific Inc. 2724 2836 2007/10/11 GE Medical Systems Hong Kong Ltd. 2783 1838 2780 9421 SA071032 CVI OZ Palm Injector (Ref: OZ 1035) FDA Z-0008-2008 Class II 2007/10/11 Suburfarm Investment and Trading Co. Ltd. SA071033 Abbott PathFinder Bone Drill-Awl-Tap (Part no. 1156-50 & 1156-60) FDA Z-0004-2008 to Z-0005-2008 Class II 2007/10/11 Abbott Laboratories Ltd. 2806 4021 SA071034 Meretek BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5-January 1, '03 FDA Z-0003-2008 Class II 2007/10/11 N/A N/A SA071035 Invacare REA Wheelchair Pelvic Belt MHRA 2007/006/025/261/001 FSCA 2007/10/11 N/A N/A MHRA 2007/009/028/291/005 FSCA 2007/10/11 N/A N/A MHRA MHRA 2007/010/002/061/003 2007/010/003/291/010 FSCA FSCA 2007/10/12 2007/10/12 Varian Medical Systems Pacific Inc. Maquet Hong Kong Limited 2724 2836 2393 9511 MHRA 2007/009/025/291/002 FSCA 2007/10/12 Stryker China Ltd 2518 6988 MHRA 2007/010/004/061/011 FSCA 2007/10/12 N/A N/A SA071041 Siemens Mobile Magnetom Harmony, Symphony and Sonata Systems MHRA 2007/008/029/291/010 FSCA 2007/10/12 Siemens Ltd. 2810 7533 SA071042 B Braun Aesculap e.motion and Columbus femoral components MHRA 2007/009/017/291/009 FSCA 2007/10/12 N/A N/A SA071043 Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153 & 2M9163) MHRA SA071036 SA071037 SA071038 SA071039 SA071040 Dale 240 Blue Tracheostomy Tube Holders and Dale 242 Blue Tracheostomy Tube Holders for Neonates to Infants Varian Real-time Position Management System (RPM) version 1.7 MAQUET ELS-Cannulae Stryker Locking Screw, Fully Threaded 5 x 70 mm (Cat. no. 18965070S, Lot/Batch no. K871252) Karl Storz Morcellator Cutter 12mm 2007/010/004/291/001 FSCA 2007/10/15 Baxter Healthcare Ltd 2807 8555 Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/10/15 Medtronic International, Ltd. 2919 1362 2384 0688 SA071044 Medtronic Sprint Fidelis Defibrillation Leads SA071045 Toshiba Nemio and Nemio XG Ultrasound systems MHRA 2007/009/026/061/007 FSCA 2007/10/16 Sanko Medical System (HK) Ltd SA071046 BD Multiset software version 2.1, 2.1.1 and 2.2 MHRA 2007/009/027/061/011 FSCA 2007/10/16 BD 2575 8668 SA071047 Otto Bock The Back 2, 3 and 4 MHRA 2006/010/011/301/002 FSCA 2007/10/16 Otto Bock Asia Pacific Limited 2598 9772 SA071048 Respironics DEAS Heated Wire Circuits MHRA 2007/009/011/291/007 FSCA 2007/10/16 N/A N/A SA071049 Masimo Rad 9 Pulse Oximeters MHRA 2007/008/014/061/002 FSCA 2007/10/16 N/A N/A SA071050 BD CellQuest Pro Software v4.0.2, 5.0.1, 5.1, 5.1.1, 5.2 and 5.2.1 MHRA 2007/009/027/061/010 FSCA 2007/10/16 BD 2575 8668 MHRA 2007/009/027/601/002 FSCA 2007/10/16 Beckman Coulter Hong Kong Ltd. 2240 6260 MHRA 2007/008/013/051/002 FSCA 2007/10/17 N/A N/A MHRA 2007/009/010/291/009 FSCA 2007/10/17 N/A N/A MHRA 2006/008/007/401/006 FSCA 2007/10/17 N/A N/A Cyberonics N/A Firm Initiated Field Action 2007/10/17 N/A N/A SA071053 Beckman Coulter Access Immunoassay Systems Ultrasensitive Insulin Reagent Kit Park House Healthcare Phase Type 1 Cell (Product code: PHSP116) Zeiss Hydromax (batches 6500 and 6271) SA071054 SensorCare Systems Control Unit SA071055 Cyberonics VNS Therapy Software, Model 250 SA071051 SA071052 SA071057 GE Healthcare Disposable Multi Absorber Canister with the EZ change Module movingpeople.net Trophy 6 electrical scooters SA071058 Pluss GZL080A Wheelchair restraint belt SA071059 Boston Scientific IMAGERT II Angiographic Cather SA071060 Siemens Digital Linear Accelerators SA071061 SA071056 MHRA 2007/008/001/601/004 FSCA 2007/10/18 GE Medical Systems Hong Kong Ltd. 2783 1838 MHRA 2007/008/014/061/005 FSCA 2007/10/18 N/A N/A MHRA Boston Scientific(HK) Ltd Health Canada 2004/012/008/401/008 2007/10/18 N/A N/A 2007/10/18 Boston Scientific (HK) Ltd 2960 7128 37632 FSCA Firm Initiated Field Action Type II 2007/10/22 Siemens Ltd. 2810 7533 Siemens C.Cam Imaging System Health Canada 37749 Type II 2007/10/22 Siemens Ltd. 2810 7533 SA071062 Siemens Mevatron Linear Accelerators Health Canada 37825 Type II 2007/10/22 Siemens Ltd. 2810 7533 SA071063 Siemens Troponin Ultra (TNI-ULTRA) Assay Health Canada 37323 Type II 2007/10/22 Siemens Ltd. 2810 7533 Medical Device Control Office N/A 68 Department of Health The Government of HKSAR SA071064 SA071066 Baxter Amiscus Separator Medtronic TSRH Silo Spinal System- Sagittal Adjusting Screw for Rod - TI Radiometer Pump waste tube for blood gas analysis kit SA071067 SA071065 Health Canada 37954 Type II 2007/10/22 Baxter Healthcare Ltd 2807 8555 Health Canada 37878 Type II 2007/10/22 Medtronic International, Ltd. 2919 1362 FDA Z-0038-2008 Class II 2007/10/22 N/A N/A Diagnostica STA Compact and STA Compact CT FDA Z-0039-2008 Class II 2007/10/22 N/A N/A SA071068 Mallinckrodt Angiomat Illumena Injector with Auxiliary Console FDA Z-0056-2008 Class II 2007/10/22 Tyco Healthcare (HKSAR) Limited 3157 7244 SA071069 I-Flow ON-Q PainBuster with OnDemand (Model PMB01) Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML for screening for Vancomycin Resistant Enterococc (Cat# P1174) Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML Microbiological media plates (Cat# P1174) Medtronic Model Model 7428 Kinetra and Model 7426 Soletra implantable neurostimulators FDA Z-0057-2008 Class II 2007/10/22 N/A N/A FDA Z-0014-2008 Class II 2007/10/22 N/A N/A FDA Z-0011-2008 Class II 2007/10/22 N/A N/A Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/10/22 Medtronic International, Ltd. 2919 1362 Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze MHRA MHRA MHRA 2007/009/014/601/003 2007/010/011/061/005 2007/010/015/291/003 FSCA FSCA FSCA 2007/10/23 2007/10/23 2007/10/23 Abbott Laboratories Ltd. Medtronic International, Ltd. N/A 2806 4021 2919 1362 N/A FDA Z-0044-2008 to Z-0046-2008 Class II 2007/10/25 BD 2575 8668 SA071077 BD Microtainer Safety Flow Lancets (Cat. No. 366356, 365759, 366357) Days Healthcare Transportable Wheelchairs MHRA 2007/005/018/401/005 FSCA 2007/10/25 N/A N/A SA071078 SA071079 Siemens Clinitest hCG Cassette Smiths Medical EMS Ventilator circuits (Product code W196-002) MHRA MHRA 2007/010/018/061/010 MDA/2007/080 FSCA MDA 2007/10/25 2007/10/25 Siemens Ltd. Smiths Medical (S.E. Asia) Ltd. 2810 7533 N/A SA071070 SA071071 SA071072 SA071073 SA071074 SA071075 SA071076 Abbott ARCHITECT cSystems Medtronic Nexframe Stereotactic System Medical Device Control Office 69 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - September 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070901 Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No N/A Firm Initiated Field Action 2007/09/03 Boston Scientific (HK) Ltd 2960 7128 MHRA 2007-008-024-061-012 FSCA 2007/09/05 Smiths Medical (S.E. Asia) Ltd. N/A JianXi FDA N/A N/A 2007/09/06 Jindun International (HK) Ltd 2851 0879 Varian Medical Systems Pacific Inc. N/A Firm Initiated Field Action 2007/09/11 Varian Medical Systems Pacific Inc. 2724 2836 Health Canada 37021 Type II 2007/09/11 BD 2575 8668 Health Canada 36862 Type II 2007/09/11 BD 2575 8668 FDA N/A Press Release 2007/09/11 Abbott Laboratories Ltd. 2806 4021 Smiths Medical Hyperflex (Model 75 FHXL80) Health Canada 30529 Type II 2007/09/14 Smiths Medical (S.E. Asia) Ltd. N/A Smiths Medical Epidural Minipack and Epidural Syringe Health Canada 29940 Type II 2007/09/14 Smiths Medical (S.E. Asia) Ltd. N/A Terumo Advanced Perfusion System 1 Base and Roller Pumps Health Canada 36601 Type II 2007/09/14 Terumo China (H.K.) Ltd. 2866 0811 Siemens Siregraph CF Health Canada 36799 Type II 2007/09/14 Siemens Ltd. 2810 7533 Health Canada 35983 Type II 2007/09/14 N/A N/A Gambro Prisma Continuous Fluid Management System Health Canada 34788 Type II 2007/09/14 Gambro China Ltd. 2839 7010 Focus Surgery Sonablate 500 Description of Product Boston Scientific Radial Jaw 4 Large Capacity Foreceps SA070902 Smith & Nephew Full radius, 4.5 mm Concave Disposable Blade (Item Code 7205335) SA070903 Jiangxi Sanxin / "Yixin" Disposable Intravenous Administration Set SA070904 Varian clinacs SA070905 BD Epicentre Microbiology Data Management SA070906 BD FA Stretococcus Group A SA070907 Abbott Blood Glucose Meter: Precision Xtra, Optium, ReliOn Ultima, Rite Aid and Kroger SA070908 SA070909 SA070910 SA070911 SA070912 Randox Laboratories Carbon Dioxide Reagent SA070913 SA070914 Source of Information* Boston Scientific(HK) Ltd Health Canada 36419 Type II 2007/09/14 N/A N/A SA070915 Conmed Linvatec Ultrapower Burr and Ultrapower Burr Diamond Health Canada 36844 Type II 2007/09/14 N/A N/A SA070916 PreMD PREVU* Point of Care Skin Sterol Test Health Canada 36800 Type II 2007/09/14 N/A N/A Boston Scientific Mach 1 Guide Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/14 Boston Scientific (HK) Ltd 2960 7128 Boston Scientific Renegade HiFlo Microcatheter Kit Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/14 Boston Scientific (HK) Ltd 2960 7128 SA070919 BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder (Catalog #368652) FDA Z-0777-2007 Class II 2007/09/14 BD 2575 8668 FDA Z-1219-2007 Class II 2007/09/14 N/A N/A FDA Z-1198-2007 to Z-1200-2007 Class II 2007/09/14 Abbott Laboratories Ltd. 2806 4021 FDA Z-1201-2007 Class II 2007/09/14 N/A N/A FDA Z-1202-2007 Class II 2007/09/14 Abbott Laboratories Ltd. 2806 4021 SA070917 SA070918 SA070920 Molnlycke Biogel Skinsense Polyisoprene Surgical Gloves, NonLatex, Sterile (Size 8) SA070921 Abbott CELL-DYN 3000, CELL-DYN 3500 and CELL-DYN 3700 Hematology Analyzer SA070922 Sendx Medical (Radiometer Capenhagen ) ABL8O FLEX Software Version 1.10 (Model no. 914863) SA070923 Abbott AxSYM System Digoxin III Reagent Pack Medical Device Control Office 70 Department of Health The Government of HKSAR SA070924 Abbott Multi-Link Vision RX Coronary Stent System SA070925 Dade Behring Dimension clinical chemistry system Total Bilirubin (TBIL) Flex reagent cartridge (Cat# DF67A) (Lot: FC8170) SA070926 Biomet Austin-Moore and Thompson Endoprotheses SA070927 Roma Medical Bed Support Handle Model 5423 SA070928 Elekta Synergy Linear accelerator XVI FDA Z-1211-2007 Class II 2007/09/14 Abbott Laboratories Ltd. 2806 4021 MHRA 2007/008/022/601/001 FSCA 2007/09/17 N/A N/A MHRA 2007/008/028/061/007 FSCA 2007/09/17 N/A N/A MHRA 2007/007/005/401/001 FSCA 2007/09/17 N/A N/A MHRA 2007/008/009/061/006 FSCA 2007/09/17 N/A N/A SA070929 Immucor Galileo MHRA 2007/008/016/401/005 FSCA 2007/09/17 Uninet Technology Ltd 2838 8423 SA070930 Chas A. Blatchford & Sons Ltd Derby Seat / Moulded Seat Insert MHRA 2006/009/019/301/001 FSCA 2007/09/17 N/A N/A SA070931 Philips MR Systems MHRA 2007/001/023/081/009 FSCA 2007/09/17 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2006/010/011/261/001 FSCA 2007/09/17 N/A N/A MHRA 2007/006/005/061/010 FSCA 2007/09/17 Abbott Laboratories Ltd. 2806 4021 MHRA 2007/008/014/601/004 FSCA 2007/09/17 Abbott Laboratories Ltd. 2806 4021 2738 2818 2277 6162 SA070932 Cascade Designs Varilite Back Support SA070933 Abbott Precision Plus Blood Glucose Electrodes / Test Strips (Lot no. 96425) SA070934 Abbott Bilirubin Calibrator : 1E66-04 SA070935 SA070936 SA070937 SA070938 SA070939 SA070940 MHRA 2007/007/025/061/016 FSCA 2007/09/17 Johnson & Johnson Medical Hong Kong FDA N/A Press Release 2007/09/18 B. Braun Medical (Hong Kong) Ltd. Stericom STE 4021 Proctoscope MHRA 2007/007/030/061/008 FSCA 2007/09/18 Roche Online TDM Tobramycin for Modular Analytics {P} System MHRA 2007/004/017/131/017 FSCA 2007/09/18 Smith & Nephew CALAXO Interference Screw MHRA 2007/008/024/291/005 FSCA 2007/09/18 BD Plastipak 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes MHRA MDA/2007/071 MDA 2007/09/18 BD 2575 8668 MHRA MDA/2007/070 MDA 2007/09/18 N/A N/A MHRA MDA/2007/073 MDA 2007/09/18 N/A N/A FDA 37014 Class I 2007/09/19 N/A N/A Abbott Muligent Acetaminophen Assay Health Canada 37211 Type II 2007/09/19 Abbott Laboratories Ltd. 2806 4021 Abbott Commander System Analyzer Class 4 Health Canada 37035 Type II 2007/09/19 Abbott Laboratories Ltd. 2806 4021 Abbott Architect System - Lipase Assay Depuy Engage Modular Revision Hip Implant Component B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR") SA070941 Universal Hospital Supplies Sterile suction connecting tubing (ref no. UN30026FFM) SA070942 Eschmann Electrosurgery bipolar unit (model TDB 60) SA070943 SA070944 SA070945 SA070946 Welch Allyn AED20 Automatic External Defibrillators N/A Roche Diagnostics (Hong Kong) Limited Smiths & Nephew Healthcare (Hong Kong) N/A 2485 7510 2648 7700 Health Canada 35873 Type II 2007/09/19 Abbott Laboratories Ltd. 2806 4021 SA070947 Abbott Freestyle Freedom Blood Glucose Monitorinf System, Freestyle Blood Glucose Monitoring System, Freestyle Mini Blood Glucose Monitoring System Health Canada 31983 Type II 2007/09/19 Abbott Laboratories Ltd. 2806 4021 SA070948 Medtronic Export XT Catheter Health Canada 36691 Type II 2007/09/19 Medtronic International, Ltd. 2919 1362 Health Canada 37173 Type II 2007/09/19 Medtronic International, Ltd. 2919 1362 Health Canada 37033 Type II 2007/09/19 Siemens Ltd. 2810 7533 SA070949 Medtronic Paceart System Software - 2006 1st Edition SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16 Medical Device Control Office 71 Department of Health The Government of HKSAR SA070951 Smiths Medical Portex Perfit Percutaneous Dilational SA070952 Smiths Medical Portex Epidural and Spinal Needle Set SA070953 28486 Type II 2007/09/19 Smiths Medical (S.E. Asia) Ltd. 2648 7700 Health Canada 30639 Type II 2007/09/19 Smiths Medical (S.E. Asia) Ltd. 2648 7700 Health Canada 24935 Type II 2007/09/19 Smiths Medical (S.E. Asia) Ltd. 2648 7700 SA070954 Siemens Lithoskop Health Canada 37262 Type II 2007/09/19 Siemens Ltd. 2810 7533 SA070955 Draeger Medical Babylog 8000 Health Canada 36919 Type II 2007/09/19 Draeger Medical Hong Kong Ltd. 2877 3077 Health Canada 37229 Type II 2007/09/19 Draeger Medical Hong Kong Ltd. 2877 3077 SA070957 Agfa Healthcare Impax DS3000 Diagnostic Pacs, Impax ES (5.0) for Cardiology, Impax for Cardiology, MA3000 Mammographic Workstation, Impax OT3000 Orthopaedic Workstation, Web 1000 Health Canada 35889 Type II 2007/09/19 Agfa Hong Kong Limited 2555 9421 SA070958 Remel Wellcogen Bacterial Antigen Test Health Canada 37147 Type II 2007/09/19 N/A N/A SA070959 Ivoclar Vivadent Odyssey Diode Laser Health Canada 37057 Type II 2007/09/19 N/A N/A MHRA MDA/2007/074 MDA 2007/09/19 N/A N/A MHRA MDA/2007/075 MDA 2007/09/19 N/A N/A FDA SA070956 Smiths Medical Graseby MS26 Syringe Driver Health Canada Draeger Medical D-Vapor SA070960 Invacare Action 2000 wheelchairs (blue frame) SA070961 Invacare Action 3 wheelchairs SA070962 Philips Isolation Transformer SA070963 Boston Scientific Advanced Bionics Patient Controller SC-5400 (Joystick Controller) Z-1234-2007 Class II 2007/09/20 Philips Electronics Hong Kong Ltd. 2876 7525 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/21 Boston Scientific (HK) Ltd 2960 7128 N/A SA070964 Bard Guidewire 70 cm x 1 mm (0.038") (Product Code: 5583705) MHRA 2007/009/010/291/012 FSCA 2007/09/21 N/A SA070965 Vertec, Hologic Fluoroscan Premier and Encore Image Intensifiers MHRA 2007/008/003/601/006 FSCA 2007/09/21 N/A N/A SA070966 Cyberonics VNS Therapy Leads MHRA 2007/008/010/061/010 FSCA 2007/09/21 GM Medical (Hong Kong) Ltd 2783 1838 MHRA 2007/007/030/051/009 FSCA 2007/09/21 Roche Diagnostics (Hong Kong) Limited 2485 7510 MHRA 2007/009/010/291/015 FSCA 2007/09/21 Medtronic International, Ltd. 2919 1362 MHRA 2007/008/028/061/009 FSCA 2007/09/24 N/A N/A MHRA 2007/006/014/601/002 FSCA 2007/09/24 Arjo Far East Ltd (Hong Kong) 2508 9553 MHRA 2007/007/024/061/008 FSCA 2007/09/24 Smiths Medical (S.E. Asia) Ltd. 2648 7700 SA070972 Stryker Radius Lcoking Caps (Cat. No. 486610000) FDA Z-1239-2007 Class II 2007/09/27 Stryker China Ltd 2518 6988 SA070973 Stryker Wheeled Electric Stretcher Model 1550 FDA Z-1009-2007 Class II 2007/09/27 Stryker China Ltd 2518 6988 SA070974 Biomet 3i LTX XP Miniplant, Dental Implant, Sterile (Model No LTX3211 and Model LTX3213) FDA Z-1221-2007 Class II 2007/09/27 N/A N/A FDA Z-1224-2007 Class I 2007/09/27 N/A N/A FDA Z-1222-2007 Class II 2007/09/27 Abbott Laboratories Ltd. 2806 4021 FDA Z-1226-2007 Class II 2007/09/27 BD 2575 8668 SA070967 Roche LightCycler 2.0 Instrument Software v 4.05.415 Deficiency and LightCycler SeptiFast Test M SA070968 Medtronic Spinal Implants: Colorado II Locking Nut#8634111 SA070969 Metrax Primedic - DefiMonitor Models DX1, XD3, XD10, XD30, XD100, XD300, XD110, XD330 SA070970 Arjo Otter lift and Arjo Pool Lift SA070971 Smiths CADD Medication Cassette Reservoir SA070975 Baxter Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161 SA070976 Abbott ARCHITECT Prolactin MasterCheck SA070977 BD ReliOn 0.5cc 3g x 8mm Bilster Pak U-100 Syringe Medical Device Control Office 72 Department of Health The Government of HKSAR SA070978 Kimberly Clark BALLARD BAL CATH Kit Kimberly Clark Health Care N/A Firm Initiated Field Action 2007/09/27 N/A N/A SA070979 Medtronic Intersept 3608 Sterile tubing (Lot 7626621) FDA Z-1227-2007 Class II 2007/09/27 Medtronic International, Ltd. 2919 1362 SA070980 Nicolet Biomedical BMSI " MicroJack" PN672-510000 FDA Z-1225-2007 Class II 2007/09/27 N/A N/A SA070981 Newport HT50 Ventilator (all Models) FDA Z-1192-2007 Class II 2007/09/27 N/A N/A SA070982 Sorin SR Single Chamber Pacemakers MHRA 2007/009/012/291/004 FSCA 2007/09/27 N/A N/A SA070983 G & S Smirthwaite SAMBA Supportive Seating System MHRA 2006/010/012/301/001 FSCA 2007/09/27 N/A N/A SA070984 Roma Medical Aids Bed Grab Handle (Model 5425) MHRA 2007/007/030/051/005 FSCA 2007/09/28 N/A N/A SA070985 Pegasus Euro Adaptor (Part No. MSM14337) MHRA 2007/003/008/081/010 FSCA 2007/09/28 N/A N/A SA070986 Varian Clinacs with Type 3 accessories MHRA 2007/009/012/061/006 FSCA 2007/09/28 Varian Medical Systems Pacific Inc. 2724 2836 SA070987 R82 Vests and Belts MHRA 2006/010/012/301/004 FSCA 2007/09/28 N/A N/A SA070988 Gambro Spectra Optia System MHRA 2007/009/019/061/002 FSCA 2007/09/28 Gambro China Ltd. 2576 2688 SA070989 B BRAUN Excia Hip Endoprosthesis, cementless, NC410T (LOT 51283009) MHRA 2007/009/017/291/010 FSCA 2007/09/28 N/A N/A Medical Device Control Office 73 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - August 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. SA070801 Description of Product BCI Autocorr Plus patient monitor SA070802 Cousin Biotech Intrmesh TI - FBIOT12020, FBIOT12025, FBIOT13030, FBIOT13050 SA070803 Philips X-Ray System BV Pulsera and Endura rel.2 with Remote Control SA070804 GE Healthcare OEC InstaTrak 3500 Plus System SA070805 GE Healthcare CardioLab/Mac-Lab IT/ComboLab IT Electrophysiology and Haemodynamic Systems Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No N/A Firm Initiated Field Action 2007/08/02 Goodwin Healthcare Ltd. 2408 8838 MHRA 2007/006/012/291/002 FSCA 2007/08/06 N/A N/A MHRA 2007/007/023/061/018 FSCA 2007/08/06 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2007/007/025/061/013 FSCA 2007/08/06 GE Medical Systems Hong Kong Ltd. 2783 1838 MHRA 2007/007/019/601/002 FSCA 2007/08/06 GE Medical Systems Hong Kong Ltd. 2783 1838 MHRA 2007/007/027/291/008, 2007/007/027/291/007 FSCA 2007/08/06 GE Medical Systems Hong Kong Ltd. 2783 1838 Source of Information* Goodwin Healthcare Ltd. SA070806 GE Healthcare Extended Range Transmitter (Catalog Part 1004070 , 1003991) SA070807 Tyco Kendall Curity Suprapubic Catheter Sets MHRA 2007/007/012/051/003 FSCA 2007/08/06 Tyco Healthcare (HKSAR) Limited 3157 7244 SA070808 Fresenius Medical Care HD Catheters MHRA 2007/007/019/291/018 FSCA 2007/08/06 Fresenius Medical Care Asia Pacific Ltd. 2802 2900 Teleflex Medical Hudson RCI Large Volume Nebuliser MHRA 2007/006/012/401/015 FSCA 2007/08/06 N/A N/A Abbott ACCELERATOR APS System (7L01-01) MHRA 2007/005/023/601/001 FSCA 2007/08/06 Abbott Laboratories Ltd. 2806 4021 Trinity Biotech Captia Measles IgM ELISA Test Kit MHRA 2007/007/009/061/003 FSCA 2007/08/06 N/A N/A FDA Z-1110-2007 Class II 2007/08/06 Medtronic International, Ltd. 2919 1362 FDA Z-1096-2007 to Z-1098-2007 Class II 2007/08/06 Abbott Laboratories Ltd. 2806 4021 FDA Z-1100-2007 to Z-1101-2007 Class II 2007/08/06 N/A N/A FDA Z-1080-2007 to Z-1085-2007 Class II 2007/08/06 N/A N/A FDA Z-1057-2007 to Z-1062-2007 Class II 2007/08/06 N/A N/A SA070809 SA070810 SA070811 SA070812 Medtronic Intersept Filtered Cardiotomy Reservior (Model 1351) SA070813 Abbott Architect AUSAB Assay SA070814 Sunnex Celestial Star MR-16 and Tri-Star Surgical Exam Light MR16 (Lamp Holder) SA070815 Allez Medical Applications 4Closure Surgical Fascia Closure System SA070816 Gebauer Pain Ease Mist Spray SA070817 Gambro Prismaflex Hemodialysis Unit SA070818 Performance Health Products AXXIS, Comfort and V-Trak MHRA 2007/007/018/061/005 FSCA 2007/08/06 Gambro China Ltd. 2839 7010 MHRA 2006/010/011/301/001 FSCA 2007/08/07 N/A N/A SA070819 Philips Brilliance 40/64 CT Scanners MHRA 2007/007/024/291/007 FSCA 2007/08/07 Philips Electronics Hong Kong Ltd. 2876 7525 SA070820 Pelican Proctoscope (Product Code 400340) MHRA 2007/007/030/061/008 FSCA 2007/08/07 N/A N/A SA070821 Medtronic SynchroMed EL Pump MHRA 2007/007/025/291/008 FSCA 2007/08/07 Medtronic International, Ltd. 2919 1362 MHRA 2007/008/002/061/011 FSCA 2007/08/08 Beckman Coulter Hong Kong Ltd. N/A FDA Z-1020-2007 Class II 2007/08/09 Vita Company Limited N/A FDA Z-1078-2007 Class II 2007/08/09 Vita Company Limited N/A Health Canada 32026 Type II 2007/08/09 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SA070822 Beckman Coulter Cytomics FC 500 Flow Cytometer with CXP Software SA070823 Cardinal Health Alaris IV Administration Infusion Sets SA070824 Cardinal Health Alaris IV Administration Infusion Sets, Low Sorbing Extension Set SA070825 Zimmer M/DN Intramedullary Fixation System Medical Device Control Office 74 Department of Health The Government of HKSAR SA070826 SA070827 Cook Fixed Core Stainless Stell Wireguide Health Canada 35942 Type II 2007/08/09 Cook Asia Ltd (1) 2781 0232; (2) 2541 1041 (1) 2781 0232; (2) 2541 1041 Cook Black Silicone Filiform Double Pigtail Stent Set Health Canada 36639 Type II 2007/08/09 Cook Asia Ltd SA070828 Boston Scientific Amplatz, CLS Cure, Internal Mamnary, Kimmy, Multipurposse and Voda Guide Catheters Health Canada 36465 Type II 2007/08/09 Boston Scientific (HK) Ltd 2960 7128 SA070829 Siemens ECAT Health Canada 36463 Type II 2007/08/09 Siemens Ltd. 2810 7533 SA070830 Health Canada 36560 Type II 2007/08/09 Siemens Ltd. 2810 7533 SA070831 Siemens Biograph 6 and Biograph 16 Health Canada 36426 Type II 2007/08/09 Siemens Ltd. 2810 7533 SA070832 Stryker Peek Electrosurgical Handle Health Canada 34278 Type II 2007/08/09 Stryker China Ltd 2518 6988 Health Canada 36506 Type II 2007/08/09 N/A N/A SA070833 Siemens Sonoline Antares and Acusion Antares Premium Edition Radiometer D711 Reference Membrane ABL7XX SA070834 Getinge Castle Steam Sterilizers Health Canada 35738 Type II 2007/08/09 N/A N/A Sensor Health Products Cary Blair Enteric Pathogen Transport Health Canada 36355 Type II 2007/08/09 N/A N/A Cybernius Nephroncare Software 5.1 Full and 5.1A5 Health Canada 34861 Type II 2007/08/09 N/A N/A Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit Health Canada 36279 Type II 2007/08/09 N/A N/A BHM Medical Nautica Patient Lift Health Canada 34044 Type I 2007/08/09 N/A N/A Health Canada 36188 Type I 2007/08/13 N/A N/A MHRA 2007/005/009/061/011 FSCA 2007/08/14 N/A N/A MHRA 2007/008/007/051/007 FSCA 2007/08/15 Draeger Medical Hong Kong Ltd. 2877 3077 MHRA 2007/007/027/291/009 FSCA 2007/08/15 N/A N/A MHRA MDA/2007/062 MDA 2007/08/15 Draeger Medical Hong Kong Ltd. 2877 3077 MHRA 2007/008/010/061/012 FSCA 2007/08/16 Philips Electronics Hong Kong Ltd. 2876 7525 MHRA 2007/008/001/291/016 FSCA 2007/08/16 N/A N/A NMPE ISOLOC Software Versions 4.2, 6.0 and 6.5 FDA Z-1145-2007 to Z-1147-2007 and Z-1152-2007 to Z-11552007 Class II 2007/08/17 N/A N/A Biomet Straight Magnum Inserter Handle FDA Z-1151-2007 Class II 2007/08/17 N/A N/A ACT VS-1000 Senator Prosthetic Foot FDA Z-1149-2007 Class II 2007/08/17 N/A N/A FDA Z-1156-2007 to Z-1158-2007 Class II 2007/08/17 N/A N/A Abbott Embrace Enteral Pump FDA Z-1141-2007 Class II 2007/08/17 Abbott Laboratories Ltd. 2806 4021 SA070851 Possis AngioJet XVG Thrombectomy Sets FDA Z-1131-2007 Class II 2007/08/17 N/A N/A SA070835 SA070836 SA070837 SA070838 SA070839 Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model 9500 SA070840 Specialised Orthotic Services Stroller buggies SA070841 Draeger Medical Anaesthesia Machine with additional monitor (device combination) SA070842 Cardinal Health Propofol-Schnider Upgrade Kit SA070843 Draeger Medical Falcon single-use paediatric Miller blades size 00, 0&1 SA070844 Philips X-Ray System Allura Xper FD20/10 Rel. 1.2., FD20 Rel.2.2. SA070845 Finsbury Orthopaedics ADEPT Acetabular Cups SA070846 SA070847 SA070848 SA070849 Accellent Precision Bipolar Device ClearGlide EVH Small SA070850 Medical Device Control Office 75 Department of Health The Government of HKSAR SA070852 FDA Z-1162-2007 Class II 2007/08/17 Cook Asia Ltd (1) 2781 0232; (2) 2541 1041 MHRA 2007/008/013/061/003 FSCA 2007/08/20 Philips Electronics Hong Kong Ltd. 2876 7525 ThermoFisher Scientific Infinity Ammonia Liquid Stable Reagent MHRA 2007/004/003/291/010 FSCA 2007/08/20 N/A N/A MAQUET Vessel Cannulae Product Code GK03 and S 1184 MHRA 2007/008/010/061/004 FSCA 2007/08/20 Maquet Hong Kong Limited 2393 9511 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/08/22 Boston Scientific (HK) Ltd 2960 7128 Abbott CELL-DYN 1700 Hematology Analyzer FDA Z-1170-2007 to Z-1171-2007 Class II 2007/08/23 Abbott Laboratories Ltd. 2806 4021 Lifescan One Touch SureSoft Lancing Device FDA Z-1165-2007 Class II 2007/08/23 Johnson & Johnson Medical Hong Kong 2738 2818 FDA Z-1173-2007 Class II 2007/08/23 FDA Z-1132-2007 to Z-1134-2007 Class II 2007/08/23 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1172-2007 Class II 2007/08/23 N/A N/A COOK PTFE Wire Guide with 3 cm flexible tip SA070853 Philips Medical System Information Centre SA070854 SA070855 SA070856 SA070857 SA070858 Boston Scientific Precision Spare Suture Sleeve SA070859 Sendx Medical ABL77 Cal Pack, Model No. 944-069 SA070860 GE Medical System Mac-Lab System, CardioLab System, ComboLab System SA070861 Sisus- Bath Helper / Sisus All In One SA070862 Louisville ApI Diagnostics APhL HRP IgG & IgM ELISA Kit, APhL HRP IgG ELISA Kit and APhL HRP IgM ELISA Kit FDA Z-1175-2007 to Z-1177-2007 Class II 2007/08/23 N/A N/A SA070863 Hill-Rom TotalCare Duo 2 MHRA MDA/2007/065 MDA 2007/08/23 N/A N/A SA070864 Femcare Nikomed Unimax Disposable Shielded Trocar and Cannula SA070865 North Eos single-use Cusco screw type vaginal specula MHRA 2007/008/020/051/005 FSCA 2007/08/23 N/A N/A MHRA MDA/2007/066 MDA 2007/08/23 N/A SA070866 Depuy SmartSeal Pressurisers MHRA 2007/007/016/061/005 FSCA 2007/08/27 2798 6080 SA070867 Biomet Optigun 4195 MHRA 2007/008/014/061/008 FSCA 2007/08/27 N/A Johnson & Johnson Medical Hong Kong N/A Health Canada 36667 Type I 2007/08/28 Gambro China Ltd. 2839 7010 Health Canada 33984 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 Terumo Advanced Perfusion System - Modules Health Canada 33985 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 Terumo Advanced Perfusion System 1 and Central Control Monitor Health Canada 33982 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 Health Canada 33981 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 Health Canada 36673 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 Health Canada 36696 Type II 2007/08/28 Terumo China (H.K.) Ltd. 2866 0811 SA070868 Gambro AK-95 SA070869 Terumo Advanced Perfusion System - Roller Pump and Centrifugual Control Unit SA070870 SA070871 SA070872 Terumo Advanced Perfusion System 1 (Model 801041) SA070873 Terumo Advanced Perfusion System 1 (Model 801040, 801041) SA070874 Terumo Sarns Modular Perfusion System 9000, 8000 and Centrifugal System SA070875 Biomerieux AacT/Alert 3D, BacT/Alert 3D 240, BacT/Alert 3D Combi SA070876 Kodak Direct View DR3000 System 80kW Generator SA070877 BD Procount Progenitor Cell SA070878 BD Difco Shigella Antiserum Poly A1 SA070879 Steris Amsco Century Medium Steam Sterilizer & SFPP Steam Sterilizer Medical Device Control Office N/A Health Canada 36531 Type II 2007/08/28 Biomerieux (Hong Kong) 2356 7033 Health Canada 36629 Type II 2007/08/28 Care Stream Health 2564 9751 Health Canada 33951 Type II 2007/08/28 BD 2575 8668 Health Canada 28852 Type II 2007/08/28 BD 2575 8668 FDA Z-1193-2007 Class II 2007/08/30 Swedish Trading Co., Ltd N/A 76 Department of Health The Government of HKSAR SA070880 Dade Behring EasyLink Informatics System Software version 3.0 FDA Z-1174-2007 Class II 2007/08/30 N/A N/A SA070881 Carmel PhaSeal Protector 14, 21 and 50 (Item No. P14, P21 and P50) FDA Z-1178-2007 to Z-1181-2007 Class II 2007/08/30 N/A N/A Medical Device Control Office 77 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - July 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product SA070701 Abbott m2000sp Instrument and m1000 Instrument Source of Information* Reference No. by Source MHRA Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No 2007/006/020/601/002 FSCA 2007/07/03 Abbott Laboratories Ltd. 2806 4201 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/07/03 Boston Scientific (HK) Ltd 2960 7128 SA070703 Roche Cortisol Reagent FDA Z-0977-2007 Class II 2007/07/05 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070704 GE Healthcare Diamond Mannographic X-Ray System FDA Z-0976-2007 Class II 2007/07/05 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070705 Varian Medical LINAC Scapel Treatment Planning System FDA Z-0978-2007 Class II 2007/07/05 Varian Medical Systems Pacific Inc. 2724 2836 SA070706 Toshiba Aplio 80 and Aplio 50 Digital Ultrasound System FDA Z-0985-2007 to Z-0986-2007 Class II 2007/07/05 Sanko Medical System (HK) Ltd 2384 0688 SA070707 Oasis Disposable Bimanuals Irrigation and Aspiration Set FDA Z-0740-2007 to Z-0742-2007 Class II 2007/07/05 N/A N/A SA070708 Philips Masimo SPO2 modules MHRA 2007/002/020/401/006 FSCA 2007/07/05 Philips Electronics Hong Kong Ltd. 2876 7525 SA070709 Abbott ClearStar enteral feeding pump MHRA 2007/006/025/061/002 FSCA 2007/07/05 Abbott Laboratories Ltd. 2806 4201 SA070710 Baxter CS3000 Apheresis Kits MHRA 2007/006/029/291/010 FSCA 2007/07/06 Baxter Healthcare Ltd 2807 8517 SA070711 Baxter Sample First Sampling System MHRA 2007/007/002/291/004 FSCA 2007/07/06 Baxter Healthcare Ltd 2807 8517 SA070712 Varian Clinacs with Type 3 accessories MHRA 2007/006/029/291/003 FSCA 2007/07/06 Varian Medical Systems Pacific Inc. 2724 2836 MHRA SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters SA070713 Integra Neurosciences Elektrotm ET630 and ET621 Boston Scientific VASOVIEWR UniportR Plus EVH System w/ SA070714 Bisector VasoView 7xB Bisector SA070715 Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS Chemistry System - Software 2007/007/003/291/024 FSCA 2007/07/06 N/A N/A Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/07/09 Boston Scientific (HK) Ltd 2960 7128 Health Canada 35306 Type II 2007/07/10 Johnson & Johnson Medical Hong Kong 2738 2818 Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel SA070716 System resolve Panel C Health Canada 35880 Type II 2007/07/10 Johnson & Johnson Medical Hong Kong 2738 2818 SA070717 Teleflex Medical Non Absorbable Stainless Steel Suture Health Canada 35784 Type II 2007/07/10 N/A N/A SA070718 Siemens Medical Simview 3000 and Simview NT Health Canada 34690 Type II 2007/07/10 Siemens Ltd. 2810 7533 SA070719 Siemens Medical Linear Accelerators Health Canada 34805 Type II 2007/07/10 Siemens Ltd. 2810 7533 SA070720 Bayer Healthcare Ascencia Contour Blood Glucose Meter Health Canada 35772 Type II 2007/07/10 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 Abbott Axsym System - Quinidine Assay and X Systems Quinidine SA070721 Assay Health Canada 35874 Type II 2007/07/10 Abbott Laboratories Ltd. 2806 4201 SA070722 Abbott Architect System - Analyzer - Class 2 Health Canada 35299 Type II 2007/07/10 Abbott Laboratories Ltd. 2806 4201 SA070723 Elekta Precise Plan Health Canada 35590 Type II 2007/07/10 N/A N/A SA070724 Gyrus CyberWand Ultrasonic Lithotriptor Health Canada 35779 Type II 2007/07/10 N/A N/A Medical Device Control Office 78 Department of Health The Government of HKSAR SA070725 Chiltern Wispa Attachment Handle Health Canada 34860 Type I SA070726 Airox Legendair Ventilator Health Canada 35588 MHRA 2007/006/028/061/010 MHRA SA070729 AIDAPT Coniston Swivel Bathers MHRA SA070730 AIDAPT Solo Bed Rail SA070727 AMO VISX WaveScan WaveFront Systems SA070728 Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum 610, 1107 2007/07/10 N/A N/A Type I 2007/07/10 Forever Health Medical Instrument Ltd 2770 9922 FSCA 2007/07/10 AMO Asia Limited 2480 3330 2006/008/017/301/002 FSCA 2007/07/10 N/A N/A 2007/003/002/401/004 FSCA 2007/07/11 N/A N/A MHRA 2007/004/024/291/010 FSCA 2007/07/11 N/A N/A GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800 SA070731 mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system FDA Z-0848-2007 to Z-0852-2007, Z-0928-2007 Class II 2007/07/12 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder FDA Z-0991-2007 Class II 2007/07/12 Smiths Medical (S.E. Asia) Ltd. FDA Z-1002-2007 to Z-1005-2007 Class II 2007/07/12 Terumo China (H.K.) Ltd. 2866 0811 SA070734 Terumo Advanced Perfusion System 1 Model 801763 and 801764 FDA Z-0929-2007 to Z-0930-2007 Class II 2007/07/12 Terumo China (H.K.) Ltd. 2866 0811 SA070735 Invacare Storm TDX Power Wheelchair FDA Z-0966-2007 Class II 2007/07/12 N/A N/A SA070736 Diagnostica Stago STA Liatest VWF: Ag FDA Z-0853-2007 Class II 2007/07/12 N/A N/A SA070737 Philips Medical HDIIXE Diagnostic Ultrasound System FDA Z-0987-2007 Class II 2007/07/12 Philips Electronics Hong Kong Ltd. 2876 7525 SA070738 Kodak Direct View DR7500 System FDA Z-0738-2007 Class II 2007/07/12 Kodak (Hong Kong) Ltd SA070739 Radiometer Medical SafeClinitubes FDA Z-0975-2007 Class II 2007/07/12 N/A N/A MHRA 2007/007/009/061/005 SA070733 Terumo Perfusion System 8000 Roller Pump, Model 8000 and Perfusion System 9000 Roller Pump Model 9000 SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway SA070741 Boston Scientific 6 French Guider Catheter Arizant Ranger Standard Flow Blood/Fluid Warming Disposable SA070742 Sets Boston Scientific(HK) Ltd MHRA 2007/006/029/601/004 SA070743 Siemens CENTRA Active BTE Hearing Instrument MHRA 2007/004/018/601/810 SA070744 BD Trypticase Soy Agar dehydrated culture media BD SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth SA070746 Boston Scientific Mach 1 Guide Catheter MHRA 2007/007/005/051/003 Boston Scientific(HK) Ltd FSCA 2007/07/13 N/A N/A Firm Initiated Field Action 2007/07/13 Boston Scientific (HK) Ltd 2960 7128 FSCA 2007/07/17 N/A N/A FSCA 2007/07/17 Siemens Ltd. 2810 7533 Firm Initiated Field Action 2007/07/17 BD 2575 8668 FSCA 2007/07/18 N/A N/A Firm Initiated Field Action 2007/07/18 Boston Scientific (HK) Ltd 2960 7128 SA070747 Terumo TenderFlow Pediatric Arterial Cannulae FDA Z-0874-2007 to Z-0885-2007 Class II 2007/07/19 Terumo China (H.K.) Ltd. 2866 0811 SA070748 Abbott Patrol Enteral Pump Set FDA Z-0888-2007 Class II 2007/07/19 Abbott Laboratories Ltd. 2806 4201 SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack FDA Z-1023-2007 to Z-1040-2007 Class II 2007/07/19 Abbott Laboratories Ltd. 2806 4021 SA070750 Ossur Total Knee Model Number 2100 FDA Z-1076-2007 Class II 2007/07/19 N/A N/A FDA Z-0989-2007 to Z-0990-2007 Class II 2007/07/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070751 GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 CArm Fluoroscopic X-Ray System Medical Device Control Office 79 Department of Health The Government of HKSAR SA070752 GE Healthcare Innova 2100 IQ and Innova 3100/3100IQ Fluoroscopic Imaging System FDA Z-1043-2007 to Z-1044-2007 Class II 2007/07/19 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070753 Cardinal Health AirLife nCPAP System Driver FDA Z-1075-2007 Class II 2007/07/19 N/A N/A SA070754 Anspach Single Use, Sterile Bone Cutting Burrs FDA Z-1008-2007 Class II 2007/07/19 N/A N/A Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/07/20 Boston Scientific (HK) Ltd 2960 7128 FDA N/A Press Release 2007/07/23 Baxter Healthcare Ltd 2807 8555 2007/07/24 N/A N/A SA070755 Boston Scientific AccuStick II with 0.38" Stainless Steel J Tip and .18" Nitinol Guidewire SA070756 Baxter Colleague Triple Channel Volumetric Infusion Pumps SA070757 Teleflex Infant Nasal CPAP Cannulae/Systems SA070758 Roche Elecsys Digoxin (Product No. 1182079322) Health Canada 35510 Type II 2007/07/25 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070759 Roche PSM QC and Validation Modules Health Canada 35915 Type II 2007/07/25 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070760 Philips Heartstart XL Monitor/Defibrillator Health Canada 36081 Type II 2007/07/25 Philips Electronics Hong Kong Ltd. 2876 7525 AGFA OT3000 Orthopaedic Workstation, MA3000 Mammographic SA070761 Workstation, Impax DS3000 Health Canada 36232 Type II 2007/07/25 Agfa Hong Kong Limited 2555 9421 SA070762 Cryolife Bioglue Rigid Applicator Tips Health Canada 35406 Type II 2007/07/25 N/A N/A SA070763 Agfa Heartlab Cardiovascular Health Canada 36244 Type II 2007/07/25 Agfa Hong Kong Limited 2555 9421 SA070764 Instrumentation Laboratory ACL TOP Coagulation Analyzer Health Canada 36144 Type II 2007/07/25 N/A N/A SA070765 Varian RadioCamera System Health Canada 35986 Type II 2007/07/25 Varian Medical Systems Pacific Inc. 2724 2836 SA070766 Roche Amplilink Health Canada 35912 Type II 2007/07/25 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070767 Elekta Precise Destop Release 4.2/5.0 Health Canada 35828 Type II 2007/07/25 N/A N/A Health Canada 36080 Type II 2007/07/25 N/A N/A Health Canada 35473 Type II 2007/07/25 N/A N/A SA070770 Maquet KION/KION-I Anasthesia Workstation MHRA 2007/011/021/401/007 FSCA 2007/07/25 Maquet Hong Kong Limited 2393 9511 SA070771 Universal Hospital Supplies Ltd Sterile Suction Connecting Tubing MHRA 2007/007/016/291/007 FSCA 2007/07/25 N/A N/A SA070772 nSpire Gas Delivery hoses MHRA 2007/006/004/601/001 FSCA 2007/07/27 N/A N/A SA070773 Stapeline circular stapler and hemorrhoidal stapler MHRA 2007/007/006/061/008 FSCA 2007/07/27 N/A N/A SA070774 HemoCue Glucose 201 RT System MHRA 2007/007/019/291/007 FSCA 2007/07/27 Science International Corp 2543 7442 MHRA 2007/002/001/401/009 FSCA 2007/07/27 Medtronic International, Ltd. 2919 1362 Class I 2007/07/27 Baxter Healthcare Ltd 2807 8555 SA070768 Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable Suture Walter Lorenz Dual Rail Distractor, Flex QC Shaft Extension, SA070769 Pediatric Distractor, QC Patient Driver, QC Removal Tool, QC Shaft Extension, QC Solid Shaft Removal Tool SA070775 Medtronic N'Vision InterStim-B Software, N'Vision Clinician Programmer, InterStim iCon Patient Programmer, InterStim Implantatble Neurostimuator, InterStim II Implantable Neurostimulator SA070776 Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD volumetric infusion pumps Medical Device Control Office FDA 80 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - June 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product SA070601 Invacare Flamingo mobile patient hoists Source of Information* Reference No. by Source Alert Type by Source MHRA MDA/2007/043 MDA Date of Issue (YYYY/MM/DD) 2007/06/01 Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System MHRA 2007/005/024/061/012 FSCA SA070603 Olympus CRP Latex OSR6x99 and Ferritin OSR6x50/OSR6x138 Reagents MHRA 2007/002/019/401/010 FSCA SA070604 BD BBL Trypticase Soy Agar w/5% Sheep Blood (TSA II) // MacConkey II Agar I Plate BD N/A Firm Initiated Field Action 2007/06/04 SA070605 Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magill endotracheal tube Kimberly Clark Health Care N/A Firm Initiated Field Action 2007/06/04 MHRA 2007/005/031/061/014 FSCA MHRA 2007/004/011/051/001 FSCA MHRA 2007/005/031/051/010 FSCA SA070607 Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User and H-31B Air Detector/Clamp User SA070608 MAQUET Mobile O.R. table 1131.12XO, BETASTAR SA070609 Kensey Nash TriActiv FX Embolic Protection System, FX Spare Shieldwire Inflators, ProGuard Spare Shieldwire Inflators SA070610 Medtronic Strata NSC Lumboperitoneal Shunt Kit SA070611 Clearview HCG Test Kits (Product Code 500158, Kit Lot no. HG0050) SA070612 Siemens AG Sienet Magicstore SA070613 Fujifilm FCR Velocity U and DR Velocity UFP Agent Contact Telephone No N/A N/A Baxter Healthcare Ltd 2807 8556 Olympus Hong Kong Ltd 2376 1805 BD 2575-8668 Goodman Medical Supplies Ltd 2332 4455 Roche Diagnostics (Hong Kong) Limited 2485 7510 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Maquet Hong Kong Limited 2393 9511 N/A N/A Medtronic International, Ltd. 2919 1362 Zenith Medical Co. Ltd 2720 2727 Siemens Ltd. 2810 7533 Fujifilm Hong Kong Limited 2317 0848 N/A N/A N/A N/A Specialists' Dental Supplies Limited N/A Bio-Rad Pacific Ltd. 2789 3300 N/A N/A N/A N/A BD 2575 8668 2007/06/04 SA070602 SA070606 Roche COBAS Taqman HCV and HIV-1 Test Local Agent 2007/06/04 2007/06/05 2007/06/05 2007/06/06 2007/06/07 FDA Z-0833-2007 to Z-0835-2007 Class II MHRA 2007/006/004/051/016 FSCA MHRA 2007/006/006/061/002 FSCA Health Canada Health Canada 35431 Type II 35223 Type II SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair Health Canada 34829 Type II SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer Health Canada 34820 Type II SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit Health Canada 34533 Type II 2007/06/08 2007/06/11 2007/06/12 2007/06/12 2007/06/12 2007/06/12 2007/06/12 2007/06/12 SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025 SA070618 Invivo Precess (3160 Series) MRI Compatible Patient Monitoring System SA070619 WALLACH T-00337 Anorectal Tip SA070620 BD Microtainer Safety Flow Lancets Medical Device Control Office Health Canada 35132 Type II MHRA 2007/005/009/061/008 FSCA MHRA MHRA 2007/005/031/051/005 MDA/2007/049 81 FSCA MDA 2007/06/12 2007/06/12 2007/06/12 Department of Health The Government of HKSAR N/A Firm Initiated Field Action 2007/06/12 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/06/12 MHRA 2007/006/006/061/023 FSCA Class II SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit Boston Scientific(HK) Ltd SA070622 Boston Scientific Impulse Angiographic Catheter SA070623 ev3 Amplatz Goose Neck Snare Kit SA070624 Wright Medical Profemur R, Revision Hip System FDA Z-0867-2007 to Z-0868-2007 SA070625 Surge Medical Solutions 15 Fr. Retrograde Cardioplegia Cannula FDA Z-0892-2007 to Z-0904-2007 Class II SA070626 Roche VANC2 Online TDM Vancomycin FDA Z-0919-2007 to Z-0920-2007 Class II SA070627 Varian Medical FramelessArray Software version 1.0 FDA Z-0905-2007 Class II SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200 FDA Z-0906-2007 Class II SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet SA070630 Sunrise Medical Groove Power Wheelchairs SA070631 Schiller Easyport Defibrillators SA070632 B Braun Intrapur Neonat Lipid I.V. Filter SA070633 Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking Cortex Screw SA070634 Boston Scientific Transend EX Guidewire SA070635 Biomet 3i EP Healing Abutment SA070636 Biomet 3i disposable twist drills FDA MHRA MHRA MHRA MHRA Boston Scientific(HK) Ltd FDA FDA Z-0926-2007 to Z-0927-2007 2007/004/017/601/805 2007/006/005/051/020 2007/006/012/061/008 2007/005/018/601/919 Class II FSCA FSCA FSCA FSCA Firm Initiated Field Action N/A Z-0922-2007 Z-0959-2007 Class II Class II SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement FDA Z-0960-2007 to Z-0965-2007 Class II SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier FDA Z-0935-2007 Class II SA070639 Zoll Lifecor Electrode Belt SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit SA070641 Thoratec TLC-II Portable VAD Driver SA070642 Bausch & Lomb Zyoptix Epi Separator and Zyoptix XP Epi Head SA070643 Smiths Medical Pneupac VR1 Ventilatory Resucitator SA070644 Sunrise Quickie SA070645 Airox Legendair Ventilator Single/Double Bran Medical Device Control Office FDA MHRA Z-0936-2007 2007/005/025/061/005 Class II FSCA MHRA 2007/006/013/061/001 FSCA Bausch & Lomb (Hong Kong) Ltd. N/A Firm Initiated Field Action MHRA 2007/003/029/601/731 FSCA Health Canada Health Canada 35442 Type II 35427 Type I 82 Boston Scientific (HK) Ltd 2960 7128 Boston Scientific (HK) Ltd 2960 7128 2007/06/13 Conmed Ltd 2854 4413 2007/06/14 Starry Medical Technology Ltd 2381 0279 N/A N/A Roche Diagnostics (Hong Kong) Limited 2485 7510 Varian Medical Systems Pacific Inc. 2724 2836 Siemens Ltd. 2810 7533 N/A N/A N/A N/A N/A N/A N/A N/A 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/14 2007/06/15 2007/06/15 2007/06/20 2007/06/20 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/21 2007/06/22 2007/06/25 2007/06/25 Smith & Nephew Healthcare Ltd. 2645 8703 Boston Scientific (HK) Ltd 2960 7128 N/A N/A N/A N/A Suntime Technology Ltd 2758 8075 N/A N/A N/A N/A N/A N/A N/A N/A Bausch & Lomb (Hong Kong) Ltd. 2213 3178 Smiths Medical (S.E. Asia) Ltd. 2317 0988 N/A N/A Forever Health Medical Instrument Ltd 2770 9922 Department of Health The Government of HKSAR SA070646 Walter Lorenz Bone File SA070647 Beckman Coulter Flow Count Fluorospheres Health Canada Health Canada 35636 Type II 35682 Type II Beckman Coulter Cytomics FC 500 Flow Cytometer (CXP Version SA070648 2.1 and 2.2) Health Canada 35691 Type II SA070649 BD Multivisc 2.5% Viscoadaptive solution Health Canada 34172 Type II 2007/06/25 2007/06/25 2007/06/25 2007/06/25 N/A N/A Beckman Coulter Hong Kong Ltd. 2240 6260 Beckman Coulter Hong Kong Ltd. 2240 6260 BD 2575 8668 N/A N/A SA070650 Inpeco Accelerator Aps System Health Canada 35448 Type II 2007/06/25 SA070651 Oxoid Metronidazole 10ug disc Health Canada 35291 Type II 2007/06/25 N/A N/A SA070652 Apex Hoy-advance-e Health Canada 34534 Type II 2007/06/25 N/A N/A MHRA 2007/006/013/061/012 FSCA N/A N/A N/A N/A SA070653 Edwards Lifesciences Vigilance II Monitor Horiba ABX Pentra Myoglobin CP Reagent, ABX Pentra Ferritin CP SA070654 Reagent MHRA 2007/006/020/061/001 FSCA SA070655 Fresenius Medical Care AV Set FMC (FA404E/FV404E) MHRA 2007/005/008/601/880 FSCA SA070656 Mediplus Coventry Valve Triple IV Peripheral Connector Set MHRA 2006/012/007/601/455 FSCA FDA Z-0950-2007 to Z-0953-2007 Class II SA070657 Abbott ARCHITECT i2000 Processing Module (List# 08C89-01, 3M74-01, 1G06-01 & 3L77-01) SA070658 Steris QFC1728 and QFC1729 Quick Connects SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit FDA Z-0967-2007 Class II 2007/07/26 2007/06/27 Fresenius Medical Care Asia Pacific Ltd. N/A 2007/06/27 N/A N/A 2007/06/28 Abbott Laboratories Ltd. 2806 4201 2007/06/28 Swedish Trading Co., Ltd N/A 2007/06/28 Roche Diagnostics (Hong Kong) Limited 2485 7510 N/A N/A Boston Scientific (HK) Ltd 2960 7128 Medtronic International, Ltd. 2919 1362 N/A N/A GM Medical (Hong Kong) Ltd 2521 9799 FDA Z-0956-2007 SA070660 Invacare Scanbed 750 (SB750) MHRA MDA/2007/056 MDA 2007/06/28 SA070661 Boston Scientific Capio Sutures Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/06/28 MHRA 2007/006/026/291/010 FSCA SA070662 Medtronic Biphasic LIFEPAK 500 AEDs SA070663 Oasis Medical Premier Edge Disposable Knives SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303) Medical Device Control Office MHRA Cyberonics 2007/006/026/291/013 Class II 2007/06/25 FSCA Firm Initiated Field Action N/A 83 2007/06/29 2007/06/29 2007/06/29 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - May 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Source of Information* Reference No. by Source SA070501 ResMed S8 CPAP Devices MHRA 2007/004/025/291/009 SA070502 Medi Prosthetic Knee Joint FDA Z-0759-2007 MHRA 2007/004/020/291/007 Description of Product SA070503 Endoart EasyBand Boston Scientific NexStentR Carotid Stent and Monorail Delivery SA070504 System Boston Scientific (HK) Ltd N/A Local Agent FSCA N/A N/A Class II 2007/05/03 N/A N/A FSCA 2007/05/03 N/A N/A Firm Initiated Field Action 2007/05/03 Boston Scientific (HK) Ltd 2960 7128 Johnson & Johnson Medical Hong Kong 2738 2818 Beckman Coulter Hong Kong Ltd. 2240 6260 SA070505 Ortho- Clinical Diagnostics VITROS troponin I reagent packs (Cat. No.: 194 9882) FDA N/A N/A SA070506 Beckman Coulter COULTER LH750 Analyzer, COULTER LH780, COULTER LH500 Series System, COULTER GEN.S MHRA 2007/004/027/291/017 FSCA SA070507 Smith & Nephew Reflection All Poly Acetabular Cup (Product Code 71353255 06DT97293) MHRA 2007/003/030/601/744 FSCA MHRA 2007/005/002/061/009 FSCA SA070508 Baxter UV Flash Compact Device SA070509 Hill-Rom AvantGuard Electtic Bed BioMerieux BacT/ALERT Classic System Software, Blood Culturing SA070510 System Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5 software B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900SA070512 02) SA070511 SA070513 Instrumentation Laboratory GEM Premier 4000 Laboratory Analyzer SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro SA070515 diagnostic SA070516 SA070517 Tyco Healthcare SealGuard TracheoSoft and SealGuard TracheoSoft PERC Edwards Lifesciences CO-Set + Closed Injectate Delivery System for Cold Injectate (Model 93600) SA070518 AFOS All endoscope storage facilities (ESF) SA070519 Olympus Flexible endoscopes SA070520 Medtronic MiniMed insulin infusion pumps SA070521 JCM Supportive seating system SA070522 Thoratec - Paracorporeal ventricular assist device Medical Device Control Office MHRA 2006/009/004/291/005 FSCA FDA Z-0773-2007 to Z-0776-2007 Class II FDA Z-0771-2007 Class II FDA Z-0783-2007 Class II FDA Z-0778-2007 Class II FDA Z-0772-2007 Agent Contact Telephone No Date of Issue (YYYY/MM/DD) 2007/05/02 Alert Type by Source Class II FDA Z-0779-2007 Class II MHRA 2006/011/016/291/003 FSCA 2007/05/04 2007/05/07 2007/05/07 2007/05/09 2007/05/09 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 2007/05/10 Smith & Nephew Healthcare Ltd. 2645 8703 Baxter Healthcare Ltd 28078556 N/A N/A Biomerieux (Hong Kong) 2356 7033 Sanko Medical Systems (H.K.) Ltd. 2384 0688 B. Braun Medical (Hong Kong) Ltd. 2277 6125 Vastec medical Ltd 2897 1912 N/A N/A N/A N/A Tyco Healthcare (HKSAR) Limited 3157 7244 N/A N/A N/A N/A Olympus Hong Kong Ltd 2376 1805 Medtronic International, Ltd. 2919 1362 N/A N/A GM Medical Pacific Ltd 2783 1838 2007/05/10 MHRA 2007/003/029/291/013 FSCA MHRA MDA/2007/035 Medical Device Alert MHRA Medtronic International, Ltd. 2007/05/11 MDA/2007/034 Medical Device Alert 2007/05/11 N/A Firm Initiated Field Action 2007/05/11 MHRA 2006/010/012/301/003 FSCA Health Canada 34992 Type I 84 2007/05/11 2007/05/14 Department of Health The Government of HKSAR SA070523 Datex-Ohmeda TEC 6 Plus Desflurane Vaporizer Health Canada 33552 Type II SA070524 GE Healthcare Revolution XR/D Health Canada 34525 Type II SA070525 GE Medical System CIC Pro Central Station Health Canada 34840 Type II SA070526 Conmed PET Eliminator Balloon Dilator SA070527 AMG Medpro Lubricating Gel SA070528 Stryker 3.5mm 90-S Serfas Energy Suction Probe Health Canada Health Canada Health Canada 34868 Type II 34958 Type II Boston Scientific(HK) Ltd N/A Firm Initiated Field Action MHRA 2007/005/003/061/014 FSCA SA070534 CIBASoft Visitint Soft Contact Lenses SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp SA070537 BD FACSCanto and FACSCanto II Software SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A SA070539 Olympus Triglyceride Reagent DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18-90SA070540 180 & NDC-18-110-180) SA070541 Conor Medsystems CoStar drug-eluting coronary stents FDA Z-0796-2007 to Z-0799-2007 Z-0795-2007 Class II Class II FDA Z-0793-2007 Class II MHRA 2007/005/002/061/006 FSCA MHRA MHRA MHRA MHRA 2007/05/14 2007/05/14 2007/05/15 N/A Boston Scientific System Drape (IVUS motor drive sterile plastic SA070530 cover) SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System 2007/05/14 2007/05/15 SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter FDA 2007/05/14 Type II Firm Initiated Field Action SA070532 Arjo Maxi Move Patient Lift with Scale 2007/05/14 34918 Boston Scientific(HK) Ltd SA070531 Medical Wire and Equipment Customers Microrings 2007/05/14 2007/005/011/291/002 2007/005/010/291/006 2007/005/010/061/013 2007/005/010/061/009 FSCA FSCA FSCA FSCA MHRA 2007/004/025/291/018 FSCA Johnson & Johnson N/A N/A 2007/05/15 GE Medical Systems Hong Kong Ltd. 2783 1838 GE Medical Systems Hong Kong Ltd. 2783 1838 GE Medical Systems Hong Kong Ltd. 2783 1838 N/A N/A N/A N/A Stryker China Ltd 2518 6988 Boston Scientific (HK) Ltd 2960 7128 Boston Scientific (HK) Ltd 2960 7128 N/A N/A 2007/05/17 Arjo Far East Ltd (Hong Kong) 2508 9553 2007/05/17 Johnson & Johnson Medical Hong Kong 2738 2818 Ciba Vision (Hong Kong) Ltd. 2814 2121 Medtronic International, Ltd. 2919 1362 N/A N/A BD 2575 8668 Olympus Hong Kong Ltd 2376 1805 Olympus Hong Kong Ltd 2376 1805 N/A N/A Biotronik Hong Kong 2877 6787 N/A N/A 2007/05/17 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/18 2007/05/22 Homecraft Rolyan Bathmaster 2000, Bathmaster Classic, SA070542 Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls) MHRA MDA/2007/039 Medical Device Alert SA070543 Nightingale Pro Axis and Pro Axis Plus MHRA MDA/2007/038 Medical Device Alert 2007/05/22 N/A N/A 2007/05/22 Smiths Medical (S.E. Asia) Ltd. 2317 0988 N/A N/A Viasys Healthcare Hong Kong Ltd 2893 0873 Abbott Laboratories Ltd. 2806 4201 Umedco 2765 8222 SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System MHRA 2007/005/016/291/014 FSCA SA070545 BREAS PV403 PEEP MHRA 2007/005/014/061/009 FSCA Viasys all paediatric ventilator breathing systems containing water SA070546 trap MHRA MDA/2007/037 Medical Device Alert SA070547 Abbott FLEXIFLO DURA-PEG Kit MHRA 2007/005/014/061/019 FSCA SA070548 Cranex Tome panoramic x-ray unit FDA Z-0816-2007 Class II Medical Device Control Office 85 2007/05/22 2007/05/22 2007/05/23 2007/05/25 Department of Health The Government of HKSAR SA070549 GE Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System SA070550 BioMerieux BacT/VIEW Software, all versions. FDA FDA Z-0815-2007 Z-0814-2007 Class II Class II 2007/05/25 2007/05/25 SA070551 Diagnostic Stago STA Compact and STA Compact CT FDA Z-0812-2007 Class II 2007/05/25 SA070552 Roche PTH (Parathyroid Hormone Test system ) FDA Z-0810-2007 Class II 2007/05/25 MHRA 2007/004/010/301/003 FSCA 2007/05/25 SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs 2007/05/25 SA070554 Draeger Medical Primus anaesthetic workstation MHRA MDA/2007/040 Medical Device Alert SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger MHRA 2007/002/001/301/001 FSCA 2007/05/25 N/A Firm Initiated Field Action 2007/05/25 SA070556 Abbott ARCHITECT STAT Troponin-I test products Abbott Laboratories Ltd. FDA N/A CDC 2007/05/28 SA070558 Roche COBAS Integra System Valproic Acid Health Canada 34875 Type I 2007/05/28 SA070559 T.H.E. Medical Reacher Bar with Small Carabiner Health Canada 34511 Type I 2007/05/28 SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution GE Medical Systems Hong Kong Ltd. 2783 1838 Biomerieux (Hong Kong) 2356 7033 N/A Roche Diagnostics (Hong Kong) Limited N/A 2485 7510 Draeger Medical Hong Kong Ltd. 2877 3077 GNB Technologies (China) Ltd N/A Abbott Laboratories Ltd. 2806 4201 AMO Asia Limited Roche Diagnostics (Hong Kong) Limited N/A 2480 3330 N/A N/A 2485 7510 N/A SA070560 Randox Laboratories Assayed Bovine Serum Health Canada 34276 Type II 2007/05/28 N/A N/A SA070561 B.Braun Ultrasite Horizon Pump IV Set Health Canada 34874 Type II 2007/05/28 B. Braun Medical (Hong Kong) Ltd. 2277 6125 SA070562 Dentsply Protper Obturators Health Canada 34652 Type II 2007/05/28 N/A N/A Philips Electronics Hong Kong Ltd. 2876 7525 Philips Electronics Hong Kong Ltd. 2876 7525 N/A N/A Beckman Coulter Hong Kong Ltd. 2240 6260 N/A N/A Medtronic International, Ltd. 2919 1362 BD 2575 8668 N/A N/A 2007/05/28 Philips Medical (1) Achieve 1.5T MRI System (2) Gyroscan SA070563 Magnetic System ACS-NT (3) Gyroscan Magnetic System T10-NT (4) Intera 3.0T MRI System (5)Intera 1.5 Master MR Health Canada 35215 Type II SA070564 Philips HD11 Ultrasound System Health Canada 35094 Type II Conmed Linvatec Medical Devices Packaged within certain Peel SA070565 Pouch Sterile Packages Health Canada 35032 Type II Beckman (1) Synchro LX20Pro (2) Synchron LX20 System SA070566 Analyzer (3) Synchron LXI725 (4) Unical DXC 600 (5) Unical DXC 6001 Analyzer (6) Unical DXC80. Health Canada 35003 Type II MHRA 2007/003/026/291/004 FSCA SA070567 BIODIS VerifyNow P2Y12 SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760 SA070569 BD Infusion Therapy System (Angiocath Catheter) 2007/05/28 2007/05/28 2007/05/28 Medtronic International, Ltd. BD Firm Initiated Field Action Firm Initiated Field Action N/A N/A 2007/05/29 2007/05/29 2007/05/29 2007/05/31 Inverness Medical BinaxNOW (a) Influenza A&B 10 Test Kit (b) SA070570 Influenza A&B 22 Test kit (c) RSV 10 Test kit (d) Nasopharyngeal Accessory pak (e) A&B Kit 10 Test kit (Japan) FDA Z-0822-2007 to Z-0826-2007 Class II SA070571 GE Medical Definium AMX 700 Digital mobile x-ray system FDA Z-0821-2007 Class II 2007/05/31 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070572 Abbott Precision Link Software (version 2.1 - 2.6) FDA Z-0709-2007 Class II 2007/05/31 Abbott Laboratories Ltd. 2806 4201 SA070573 CP Medical Surgical Suture FDA Z-0807-2007 Class II 2007/05/31 N/A N/A FSCA 2007/05/31 N/A N/A SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem Medical Device Control Office MHRA 2007/005/022/061/006 86 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - April 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No MHRA 2007/003/028/601/729 FSCA 2007/04/02 Siemens Ltd. 2870 7533 SA070402 GE Healthcare OEC 9900 MHRA 2007/003/029/181/004 FSCA 2007/04/03 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups MHRA 2007/002/006/081/001 FSCA 2007/04/03 Smith & Nephew Healthcare Ltd. 2645 8703 SA070404 Baxter Haemodialysis Instruments Addenda MHRA 2007/003/016/291/002 FSCA 2007/04/04 Baxter Healthcare Ltd. 2807 8556 MHRA 2007/003/022/601/706 FSCA 2007/04/04 N/A N/A SA070406 GE Healthcare Smart Box Health Canada 32004 Type II 2007/04/10 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select Health Canada 33345 Type II 2007/04/10 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 345,133,451,434,517 Type II 2007/04/10 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 34484 Type II 2007/04/10 GE Medical Systems Hong Kong Ltd. 2783 1838 2783 1838 MDCO Ref. No. SA070401 SA070405 Description of Product Siemens Medical Solutions IMMULITE One TNF-Alpha Lot 147 (LKNF 147) Arcomedical Infusion Ltd - 3101-PVJ (FSB502) Needlefree solution set (Batch C8227) GE Healthcare - OEC Uroview 2800, OEC Miniview 6800, OEC Flexiview 8800 GE Healthcare OEC Radiographic/Fluoroscopic Systems, Model (1) SA070409 Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800 (5) 9800 SA070410 GE Healthcare - Instatrak 3500 System SA070408 Health Canada 33329 Type II 2007/04/10 GE Medical Systems Hong Kong Ltd. SA070411 Depuy Asr Acetabular Cup System Health Canada 34519 Type II 2007/04/10 DePuy Inc (J&J) SA070412 Smiths Medical - Fluid Warming System Health Canada 34536 Type II 2007/04/10 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump Health Canada 34277 Type II 2007/04/10 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SA070414 Siemens Medical - Lithoskop Health Canada 34448 Type II 2007/04/10 Siemens Ltd. 2810 7533 SA070415 Conmed Padpro Adult Radiotranslucent Pad Health Canada 34510 Type I 2007/04/10 Conmed Limited 2854 4413 SA070416 Trudell Medical Marketing Limited - ABG kit Health Canada 34214 Type II 2007/04/10 N/A N/A SA070417 Stentor (Philips Medical Systems) - Isite Pacs Health Canada 34305 Type II 2007/04/10 Philips Electronics Hong Kong Ltd. 2876 7525 SA070418 Cryocath Flexcath Steerable Sheath Health Canada 34518 Type II 2007/04/10 N/A N/A SA070419 Dentalez Inc - End Cup Health Canada 34543 Type II 2007/04/10 N/A N/A SA070420 Physio-Control LIFEPAK 20 Defibrillator/Monitor Medronic International Ltd N/A Firm Initiated Field Action 2007/04/10 Medtronic International, Ltd. 2919 1362 Medical Device Control Office 87 2738 2894 Department of Health The Government of HKSAR SA070421 Philips Medical - Brilliance Computed Tomography System Health Canada 34499 Type II 2007/04/10 Philips Electronics Hong Kong Ltd. 2876 7525 SA070422 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System Health Canada 33615, 33616 Type II 2007/04/10 Gambro China Ltd. 2576 2688 Johnson & Johnson Medical Hong Kong N/A N/A 2007/04/10 Johnson & Johnson Medical Hong Kong 2738 2818 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/11 Boston Scientific (HK) Ltd 2690 7218 SA070425 Remington Medical Prostate Biopsy needle FDA Z-0673-2007 Class II 2007/04/11 N/A N/A SA070426 Intuitive brand Da Vinci S Surgical System FDA Z-0670-2007 Class II 2007/04/11 N/A N/A SA070427 Aspyra Inc CyberMed Version 2.1 Pharmacy Software FDA Z-0686-2007 Class II 2007/04/11 N/A N/A SA070428 NDO Surgical Plicator EPS Plication System FDA Z-0685-2007 Class II 2007/04/11 N/A N/A Zimmer Trabecular Metal Reserse Shoulder System SA070429 Instrumentation Conical Reamer FDA Z-0675-2007 Class II 2007/04/11 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 SA070423 Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular stapler SA070424 Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY and VITALITY 2 (ICD) SA070430 Siemens syngo Dynamics 5.0 Workplace Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guid SA070432 Terumo Perfusion System 8000 Base, Model 8000 SA070431 FDA Z-0652-2007 Class II 2007/04/11 Siemens Ltd. 2810 7533 FDA Z-0647-2007 to Z-0651-2007 Class II 2007/04/11 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 Terumo China (H.K.) Ltd. 2866 0811 (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 FDA Z-0655-2007 to Z-0659-2007 Class II 2007/04/11 SA070433 Cook ATB Advance PTA Dilation Catheter, REF G26887 FDA Z-0665-2007 Class II 2007/04/11 SA070434 BD 366358 LANSCET SFL GREEN BD N/A Firm Initiated Field Action 2007/04/11 BD 2575 8668 MHRA 2007/003/028/081/005 FSCA 2007/04/11 Smiths Medical (S.E. Asia) Ltd. 2317 0988 FDA Z-0660-2007 Class II 2007/04/11 N/A N/A FDA Z-0722-2007 Class II 2007/04/12 Abbott Laboratories Ltd. 2806 4201 SA070438 BD 30ml Syringe Luer-Lok tip Sterile (Reorder number 309650) FDA Z-0719-2007 Class II 2007/04/12 BD 2575 8668 Abott CELL-DYN 3200 Dilutent / Sheath Reagent (List number SA070439 03H79-01) FDA Z-0706-2007 Class II 2007/04/12 Abbott Laboratories Ltd. 2806 4201 Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer users and Level 1 H31-B Air Detector/ Clamp User Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument Part SA070436 Number: 400172-04 SA070435 SA070437 SA070440 Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no 7D71-30 and 7D71-20) Integra Biotechnical ProWord Shoulder Postoperative Dressing and Cold Therapy System (Model number AR-1625) FDA Z-0714-2007 Class II 2007/04/12 N/A N/A Cenorin ThermaSure Medical Device Drying Cabient series 130, SA070441 300 AND 1000 FDA Z-0711-2007 to Z-0713-2007 Class II 2007/04/12 N/A N/A SA070442 Radiometer America ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 FDA Z-0705-2007 Class II 2007/04/12 N/A N/A SA070443 Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001761) FDA Z-0701-2007 Class II 2007/04/12 N/A N/A FDA Z-0720-2007 to Z-0721-2007 Class II 2007/04/12 N/A N/A Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/16 Boston Scientific (HK) Ltd 2960 7128 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/16 Boston Scientific (HK) Ltd 2960 7128 SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0 SA070445 Boston Scientific Percutaneous Track Kit with Amplaz Dilator and Sheath Kit SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System Medical Device Control Office 88 Department of Health The Government of HKSAR SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators Boston Scientific(HK) Ltd Firm Initiated Field Action N/A 2007/04/16 Boston Scientific (HK) Ltd 2960 7128 SA070448 HemoCue Glucose Systems MHRA 2007/033/019/291/006 FSCA 2007/04/16 Science International Corp 2543 7442 SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60) MHRA 2007/004/002/601/745 FSCA 2007/04/16 Abbott Laboratories Ltd. 2806 4201 LifeScan United Kingdom and Ireland N/A N/A 2007/04/17 Johnson & Johnson Medical Hong Kong 2738 2818 MHRA 2007/004/011/291/009 FSCA 2007/04/18 N/A N/A MHRA 2007/002/008/601/580 FSCA 2007/04/18 N/A N/A 2007/04/18 N/A N/A SA070450 LifeScan One Touch Ultra blood glucose test strips BIOMET 3i Conical 17 Degree Angeled Abutment 4.1mm (D) x 2mm (H) (AC4217 Lot No 639098F-5) Dade Bethring Syva Emit 2000 Phenobarbital Assay, 4D019UL, lot SA070452 W6 SA070453 All Shelhigh medical devices SA070451 FDA Ortho- Clinical Diagnostics VITROS Immunodiagnostics Products SA070454 HBsAg Reagent Pack (Cat# 6801322) FDA Z-0747-2007 Class II 2007/04/19 Healthcare Diagnositcs N/A SA070455 Roche CoaguChek Brand PT Test Strips FDA Z-0737-2007 Class II 2007/04/19 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322) FDA Z-0736-2007 Class II 2007/04/19 Roche Diagnostics (Hong Kong) Limited 2485 7510 FDA Z-0734-2007 to Z-0735-2007 Class II 2007/04/19 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070457 Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP 450 Test, CE-IVD, M/N4381866190 SA070458 Bio-Rad tox/See Drug Screen Test FDA Z-0733-2007 Class II 2007/04/19 Bio-Rad Pacific Ltd. 2789 3300 FDA Z-702-2007 to Z-703-2007 Class II 2007/04/19 N/A N/A SA070460 Joerns Healthcare Sunrise Medical-Hoyer Advance Patient Lifts FDA Z-0727-2007 Class II 2007/04/19 N/A N/A SA070461 Coloplast Sea-Clens Wound Cleanser (#11701-159-36, #1063) Dade Bethring Microgenics MAS Controls Cardiolmmune XL SA070462 Control (CAI-XL1. CAI-XL2, CAI-XL3, CAI-XL4) Mckinley Medical MicroSet NDEHP with 1.2 flter and SR segment SA070463 (Product code 120-112XSFV) AngioDynamics Starburst 25cm, Starburst XL 25cm and Starburst SA070464 SemiFlex 25cm FDA Z-0710-2007 Class II 2007/04/19 Coloplast (Hong Kong) Ltd 3628 7488 MHRA 2007/004/003/601/746 FSCA 2007/04/20 N/A N/A MHRA 2007/004/010/131/012 FSCA 2007/04/20 N/A N/A SA070459 AMS DURA-II Distal Tips and Universal Tips (Product no 72009340 and 72009361) MHRA 2007/004/010/131/006 FSCA 2007/04/20 N/A N/A MHRA 2007/004/013/051/003 FSCA 2007/04/20 CONMED LTD 2854 4413 SA070466 Teleflex Medical Infant Nasal CPAP System Health Canada 34613 Type II 2007/04/23 SA070467 GE Healthcare Infinia Gamma Camera Health Canada 33213 Type II 2007/04/23 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070468 Alcon LADAR6000TM Excimer Laser Health Canada 34303 Type II 2007/04/23 Alcon Hong Kong Ltd 2568 0636 SA070469 Medtronic U-Clip -Removal Tool Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01 SA070470 and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25, Unomedical Drain-Fix 680M and 685M, Central Gard 667M and SA070471 668M , Epi-Fix 670M Health Canada 34068 Type II 2007/04/23 Medtronic International, Ltd. 2919 1362 MHRA 2007/004/012/601/784 FSCA 2007/04/23 Abbott Laboratories Ltd. 2806 4201 MHRA 2007/003/016/081/007 FSCA 2007/04/23 N/A N/A Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/23 Boston Scientific (HK) Ltd 2960 7128 Varian Medical Systems Pacific Inc. N/A Firm Initiated Field Action 2007/04/23 Varian Medical Systems Pacific Inc. 2724 2836 MHRA 2007/004/017/601/800 FSCA 2007/04/24 Abbott Laboratories Ltd. 2806 4201 FDA Z-0767-2007 Class II 2007/04/27 N/A N/A FDA Z-0761-2007 Class II 2007/04/27 N/A N/A FDA Z-0752-2007 to Z-0754-2007 Class II 2007/04/27 N/A N/A FDA Z-0749-2007 to Z-0751-2007 Class II 2007/04/27 Siemens Ltd. 2810 7533 SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200) SA070472 Boston Scientific SypGlassT Light Source SA070473 SA070474 SA070475 SA070476 SA070477 Varian OBI with cone beam computed tomography (Versions 1.2 and 1.3) AxSYM Total β - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A0622) and Speciment Diluent (List no. 9C21-50) Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422 Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580T2ASM2 RITA Starburst XL, Starburst, Starburst MRI SemiFlex SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363) Medical Device Control Office 89 Department of Health The Government of HKSAR SA070479 Sunrise Medical DeVibiss PD1000A Pulse Dose Oxygen Conserving Cylinder and 535D-X CF Continuous Flow Cylinder FDA Z-0731-2007 to Z-0732-2007 Class II 2007/04/27 N/A N/A MHRA 2007/004/016/121/001 FSCA 2007/04/27 Bio-Rad Pacific Ltd. 2789 3300 SA070481 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System Health Canada 34562 Type I 2007/04/30 Gambro China Ltd. 2576 2688 SA070482 Gambro Cartridge Blood Tubing 003409410 Health Canada 34726 Type II 2007/04/30 Gambro China Ltd. 2576 2688 SA070483 Phillips Medical Voxel Q Field Upgrade to ACQSIM Baxter Healthcare Colleague 3 Volumetric Infusion Pump, SA070484 Colleague Guardian 3 CXE Color Pump, Colleague Volumetric SA070485 Toshiba Aplio XV Ultrasound System Siemens Linear Accelerators, Digital Linear Accelerator and Oncor SA070486 Impression IMRT Health Canada 34838 Type II 2007/04/30 Philips Electronics Hong Kong Ltd. 2876 7525 Health Canada 34787 Type II 2007/04/30 Baxter Healthcare Ltd 2807 8556 Health Canada 34318 Type II 2007/04/30 Sanko Medical Systems (H.K.) Ltd. 2384 0688 Health Canada 34725 Type II 2007/04/30 Siemens Ltd. 2810 7533 SA070480 BIO-RAD EVOLIS SYSTEMS SA070487 Maquet HL30 Perfusion System SA070488 Smiths Medical CADD Administration Sets and CADD Prizm Administration Sets SA070489 Dade Behring BEP2000 ADV System Release Kit 1.23.3 SA070490 Zerusa Guardian Hemostasis Valve FH100 SA070491 西安西京醫療用品有限公司"希健醫用" Extracorporeal circulating set Medical Device Control Office Health Canada 34587 Type II 2007/04/30 Maquet Hong Kong Limited 2393 9511 Health Canada 34794 Type II 2007/04/30 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Health Canada Health Canada 34859 34684 Type II Type II 2007/04/30 2007/04/30 N/A N/A N/A N/A SFDA N/A N/A 2007/04/30 N/A N/A 90 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - March 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent SA070301 Taut Intraducer Peritoneal Catheter FDA Z-0428-2007 Class II 2007/03/01 N/A Agent Contact Telephone No N/A Abbott - Imx Sirolimns Reagent Pack (Lots# 053389, 053457, SA070302 063650, 063973, 064459, 064772, 064750, 065076) FDA Z-0501-2007 Class II 2007/03/01 Abbott Laboratories Ltd. 2806 4201 SA070303 Siemens Medical Solutions- Symbia S Series SPECT & SPECT-CT FDA Z-0548-2007 to Z-0549-2007 Class II 2007/03/01 Siemens Ltd. 2870 7533 FDA Z-0554-2007 Class II 2007/03/01 N/A N/A FDA Z-0424-2007 to Z-0426-2007 Class II 2007/03/01 MHRA 2007/001/025/081/004 MDCO Ref. No. Description of Product SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625 SA070305 Arjo - Sara Active Sling, patient Lift SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435) SA070308 Kjaerulff Lift Stand Aid (art no: 400640434) BD N/A Arjo Far East Ltd (Hong Kong) 2508 9553 Field Safety Corrective Action Firm Initiated Field Action Field Safety Corrective Action 2007/03/01 N/A N/A 2007/03/01 BD 2575 8668 2007/03/02 N/A N/A MHRA 2006/09/006/401/013 SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000 Health Canada 34055 Type II 2007/03/05 Agfa Hong Kong Limited 2555 9421 SA070310 Olympus - PK7200 Microplate System (Software) Health Canada 34196 Type II 2007/03/05 United Tecnica Limited N/A SA070311 Waverleyglen Systems Ltd - Portable Reacher 24" and 36" Health Canada 34150 Type I 2007/03/05 N/A N/A SA070312 Hospira - Enteral Plumset with Integral Container Health Canada 33456 Type II 2007/03/05 N/A N/A MHRA 2006/011/027/291/008 Field Safety Corrective Action 2007/03/05 N/A N/A MHRA 2007/002/014/081/006 Field Safety Corrective Action 2007/03/06 Medtronic International, Ltd. 2919 1362 Health Canada N/A Alert to Hospital 2007/03/06 N/A N/A SA070316 Bausch & Lomb ReNu MultiPlus contact lens care solutions Bausch & Lomb (Hong Kong) Ltd. N/A Firm Initiated Field Action 2007/03/06 Bausch & Lomb (Hong Kong) Ltd. 2213 3176 SA070317 Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/03/07 SA070318 Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400; 01-15401 & 01-15407) FDA Z-0521-2007 Class II 2007/03/08 Stryker China Ltd 2518 6988 SA070319 BD Integra 1ml Syringe with Retracting Guide Needle 1 ml 29g 1/2' (0.33 x 13mm) Re-Order No. 305282 U-100 insulin (Lot# 6073436) FDA Z-0582-2007 Class II 2007/03/08 BD 2575 8668 SA070320 Hospira - LifeShield Latex-Free Primary I.V. Pump Set (List 1216301, lot 39-126-5H) FDA Z-0542-2007 Class II 2007/03/08 N/A N/A SA070321 Exactech Optetrak All Poly Tibial PS Component, Knee prothesis catalog # 204-11-13, serial numbers 0900529 - 0900532 FDA Z-0522-2007 Class II 2007/03/08 N/A N/A FDA Z-0550-2007 to Z-0553-2007 Class II 2007/03/08 N/A N/A FDA Z-0546-2007 Class II 2007/03/08 N/A N/A SA070313 Huntleigh Healthcare Contoura 880 beds SA070314 Medtronic Ltd - GATEKEEPER Reflux Repair System Model 3770GK SA070315 Pine Medical Rotating Waist Restraint Clark Biocompatible Hemoperfusion Cartridge, Sorbent: SA070322 Heparinized polymer over activated carbon, 50ml, 100ml, 175ml & 250ml (Lot # 564 - 577) SA070323 LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223 (Code C6310, C6324 and C6297) Medical Device Control Office 91 Medronic International Ltd 2919 1362 Department of Health The Government of HKSAR SA070324 Preservation Uni-Compartmental Knee fixed-bearing Tibial Tray Components (size 1 - 5 ) MHRA 2006/011/022/081/001 SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation MHRA 2007/002/001/081/014 SA070326 ConMed Frazier and Poole Suction Instruments MHRA 2006/011/023/081/011 SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans MHRA 2006/012/007/081/004 Boston Scientific (HK) Ltd N/A SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs) SA070329 Timesco Optima XL Stubby Laryngoscope Handles MHRA 2006/012/001/291/002 SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A) MHRA 2007/003/001/181/002 SA070331 Vygon Lectro Cath Plus150 cm ext. Line (batch: 0624291A) SA070332 VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 3002-013-1 and 30-02-913-1 MHRA MHRA 2007/003/008/081/001 2006/011/001/081/009 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2007/03/08 DePuy Inc (J&J) 2007/03/08 DePuy Inc (J&J) 2007/03/08 N/A N/A Field Safety Corrective Action 2007/03/08 N/A N/A Firm Initiated Field Action 2007/03/09 Boston Scientific (HK) Ltd 2960 7128 2007/03/09 N/A N/A 2007/03/09 N/A N/A 2007/03/12 N/A N/A 2007/03/13 N/A N/A 2007/03/14 Beckman Coulter Hong Kong Ltd. 2240 6260 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2738 2894 2738 2894 SA070333 Beckman Coulter FP1000 Cell Preparation System MHRA 2007/003/006/081/015 Timesco Callisto Macintosh size 3 (adult) single-use laryngiscope SA070334 blade (part # DS.3940.150.20/21) (Affected lots: GE, GF, GG, GH, GI, GJ, GK, GL, HA) MHRA MDA/2007/021 Medical Device Alert 2007/03/14 N/A N/A Hamilton Medical N/A Firm Initiated Field Action 2007/03/14 N/A N/A FDA Z-0578-2007 to Z-0579-2007 Class II 2007/03/15 Siemens Ltd. 2870 7533 FDA Z-0597-2007 Class II 2007/03/15 N/A N/A FDA Z-0577-2007 Class II 2007/03/15 N/A N/A FDA Z-0545-2007 Class II 2007/03/15 Siemens Ltd. 2870 7533 Alcon Custom-Pak (Part# 10975-02; 2638-17; 4917-54; 6515-51; 11148-02) FDA Z-0560-2007 to Z-0564-2007 Class II 2007/03/15 Alcon Hong Kong Ltd 2568 0636 Wright Medical Technology Gladiator Bipolar Hip Prothesis (REF: SA070341 GLBP-2241; GLBP-3650; GLBP-3651L GLBP-3652; GLBP-3653; GLBP-3654; GLBP-3655) FDA Z-0567-2007 to Z-0573-2007 Class II 2007/03/15 Starry Medical Technology Ltd 2381 0279 FDA Z-0574-2007 Class II 2007/03/15 N/A N/A 2007/03/15 N/A N/A 2007/03/15 Boston Scientific (HK) Ltd 2960 7128 Medical Device Alert 2007/03/16 Boston Scientific (HK) Ltd 2960 7128 Field Safety Corrective Action 2007/03/16 Smith & Nephew Healthcare Ltd. SA070335 Hamilton Medical Galileo Classic and Gold ventilators Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray SA070336 system (model number 5904466& 7555365) Kensey Nash Corp. - ThromCat Thrombectomy Catheter System 7F2.5-7.0MM 150CM (Lot#54877, 55318, 55218, 54821) EKOS EndoWave Infusion System and EKOS Lysus Infusion SA070338 System (All models with Serial no. greater than and equal to 0610XXXX-XXX) Siemens Medical Solutions Sample Management System Software SA070339 for in vitro diagnostic testing Product # 030102-03 SA070337 SA070340 Abiocor AB5000 Console Circulatory Support System (Catalog no. 0015-000) Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, SA070343 length tubing (batches C8237) SA070342 SA070344 Boston Scientific Carotid Wallstent endoprosthesis Boston Scientific Ltd: Vitality and Assure implantable cardioverter SA070345 defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) Families SA070346 Smith & Nephew RF DENERVATION PROBE (ITEM CODE 7210271; DESCRIPTOR 10 CM, LOT# 602561) Medical Device Control Office MHRA Boston Scientific (HK) Ltd 2007/003/007/601/661 N/A Field Safety Corrective Action Firm Initiated Field Action MDA/2007/023 MHRA MHRA 2007/003/012/081/010 92 2645 8703 Department of Health The Government of HKSAR SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN SA070348 SA070349 SA070350 SA070351 SA070352 SA070353 SA070354 SA070355 SA070356 SA070357 SA070358 SA070359 SA070360 SA070361 Abbott - AxSYM Toxo LgG (List no 9K08-20; Lot no 42249HN00, 42249HN01, 43528HN00, 43528HN01) Gyrus ACMI Tripolar Ultra Cutting Foreceps (Ref no. TRU5-32, 006689-901, 006689-903) Remel MacConkey Agar w/Sorbitol, growth medium, catalog R01556 (Lot#506069) StayFix Fixation Device (REF 680ME, REF 685ME, REF670M) Cook Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating (Recorder no. C-UTLMY-701J-RSC-ABRM-HC-FST-A) iSight PACS version 3.5 Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System (Catalog # 164268) Baxter Healthcare Corp - Clearlink Paclitaxel IV Admin Set and Interlink Paclitaxel IV Admin Set Haemodialysis Machine: Integra manufactured by Gambro DePuy ASR Taper Sleeve Adaptor 9/10 (-3) and DePuy ASR Taper Sleeve Adaptor (Code no 999800313 and 999800300) Arcomedical Infusion Ltd - 3110-J (FSB499) Burette Set (Batch H24563) Biomerieux BacT/ALERT FN Culture Bottle (Product no 259793, lot no 1015145) Maquet Cardiopulmonary AG - Product Code H7101 (Lot 218333, 221734, 223245) SA070362 Karma Mobility - Martin (KM-8520 series) SA070363 Clearview Simplify D- Dimer( Kit lot no. PX018A, Batch no 682-024) BD human IL-15 recombinant protein (Mat. No. 554630) and SA070364 recombinant soluble dimeric human HLA-A2:Ig (Mat. No. 551263) SA070365 Boston Scientific Expo Selective Angiographic Catheter SA070366 Varian FastPlan treatment planning system for stereotactic radiosurgery (versions 5.1 and below) SA070367 Medicare Technology 716 Wheelchair Lap Belt Smith & Nephew InterTan Subtrochanteric Lag Screw Driver SA070368 (Product Code: 71674068) SA070369 GE Healthcare OEC 9800 Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys SA070370 Phacoemulsificator BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached SA070371 Holders SA070372 Puritan Bennett 840 Ventilator System Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, SA070373 length tubing (batches C8218) Boston Scientific Polarcath Peripheral Dilatation System Inflation SA070374 Unit Medical Device Control Office 2007/003/013/081/005 Field Safety Corrective Action 2007/03/20 N/A N/A 2007/003/012/601/683 Field Safety Corrective Action 2007/03/20 Abbott Laboratories Ltd. 2806 4201 FDA Z-0613-2007 to Z-0615-2007 Class II 2007/03/21 N/A N/A FDA Z-0621-2007 Class II 2007/03/21 N/A N/A FDA Z-0629-2007 Class II 2007/03/21 N/A N/A MHRA MHRA (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 FDA Z-0637-2007 Class II 2007/03/21 FDA FDA Z-0616-2007 Z-0639-2007 Class II Class II 2007/03/21 2007/03/21 Philips Electronics Hong Kong Ltd. Abbott Laboratories Ltd. 2876 7525 2806 4201 FDA Z-0617-2007 Class II 2007/03/21 Terumo China (H.K.) Ltd. 2866 0811 Class II 2007/03/21 Baxter Healthcare Ltd 2807 8556 Medical Device Alert Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2007/03/21 Gambro China Ltd. 2576 2688 2007/03/21 DePuy Inc (J&J) 2007/03/21 N/A N/A 2007/03/21 Biomerieux (Hong Kong) 2356 7033 Health Canada 34385 MHRA MDA/2007/027 MHRA 2007/003/016/081/002 MHRA 2007/003/015/601/689 MHRA 2007/003/001/601/640 MHRA 2007/002/022/291/001 2738 2894 2007/03/21 Maquet Hong Kong Limited 2393 9511 Field Safety Corrective Action 2007/03/21 N/A N/A MHRA 2006/003/014/291/019 FDA Z-0594-2007 Class II 2007/03/21 N/A N/A BD N/A Firm Initiated Field Action 2007/03/21 BD 2575 8668 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/03/22 Boston Scientific (HK) Ltd 2960 7128 Varian Medical Systems Pacific Inc. N/A Firm Initiated Field Action 2007/03/22 Varian Medical Systems Pacific Inc. 2724 2836 MHRA 2006/009/019/181/013 Field Safety Corrective Action 2007/03/26 N/A N/A 2007/03/26 Smith & Nephew Healthcare Ltd. 2007/03/26 GE Medical Systems Hong Kong Ltd. 2783 1838 2007/03/26 N/A N/A 2007/03/27 BD 2575 8668 2007/03/28 Tyco Healthcare (HKSAR) Limited 3157 7244 2007/03/28 N/A N/A 2007/03/29 Boston Scientific (HK) Ltd 2960 7128 MHRA 2007/001/017/291/001 MHRA 2006/010/013/291/005 MHRA 2007/001/016/081/010 BD N/A MHRA 2007/003/021/081/002 MHRA 2007/003/020/601/694 Boston Scientific (HK) Ltd N/A 93 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Firm Initiated Field Action Field Safety Corrective Action Field Safety Corrective Action Firm Initiated Field Action 2645 8703 Department of Health The Government of HKSAR SA070375 Viasys VELA Ventilator SA070376 BioMerieux BacT/ALERT FA Culture Bottles BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1) SA070377 diagnostic data management system SA070378 Gebauer - Salivart Oral Moisturizer Z-0638-2007 Z-0643-2007 Class II Class II FDA Z-0644-2007 Class II FDA Z-0497-2007 FDA FDA SA070379 Immucor Gamma Capture-R Select plates MHRA SA070380 CPS Direct SL slittable outer guide catheter MHRA SA070381 Arcomedical Ltd - 3101PNOY (FSB542) (Batch number C7944) MHRA SA070382 HoMedics Thera-P Heating Pads Medical Device Control Office FDA Class II Field Safety Corrective 2007/001/002/291/001 Action Field Safety Corrective 2007/003/021/081/003 Action Field Safety Corrective 2006/009/029/401/001 Action Z-0622-2007 to Z-0626-2007 Class I 94 2007/03/29 2007/03/29 Viasys Healthcare Hong Kong Ltd Biomerieux (Hong Kong) 2893 0873 2356 7033 2007/03/29 Biomerieux (Hong Kong) 2356 7033 2007/03/29 N/A N/A 2007/03/29 N/A N/A 2007/03/29 N/A N/A 2007/03/30 N/A N/A 2007/03/30 N/A N/A Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - February 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No. FDA Z-0341-2007 to Z0342-2007 Class II 2007/02/01 N/A N/A FDA Z-0350-2007 Class II 2007/02/01 Maquet Hong Kong Limited Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat. No 511-20 (Lot#29892) FDA Z-0361-2007 Class II 2007/02/01 N/A N/A Suros Surgical ATEC Breast Biopsy System handpiece for use with SA070204 ATEC Breast Biopsy and Excision System, disposable, sterile, Part no. 0912-20 (Lot: 611018) FDA Z-0362-2007 Class II 2007/02/01 N/A N/A SA070205 Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85 FDA Z-0363-2007 Class II 2007/02/01 Otto Bock Hong Kong 2598 9772 Abbott - i-STAT PT/INR Cartridge prothrombin time rest in vitro SA070206 diagnostic (product list#04J50-01 & 04J50-02; catalog# 420200; Ref.: 04J50-01 24) FDA Z-0364-2007 Class II 2007/02/01 Abbott Laboratories Ltd. 2806 4201 Terang Nusa Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves (Item no. MDS207060) FDA Z-0365-2007 Class II 2007/02/01 N/A N/A Philips Integris Allura System angiographic- Allura 9 F/C, Allura SA070208 Mono X-Ray System, Allura FD 10 FX, Allura FD20 x-ray, FD 10/10 x-ray system and FD 20/10 x-ray system FDA Z-0366-2007 to Z-0371-2007 Class II 2007/02/01 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-0373-2007 Class II 2007/02/01 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-0376-2007 Class II 2007/02/01 Bio-Rad Pacific Ltd. 2789 3300 FDA Z-0377-2007 Class II 2007/02/01 Firm Initiated Field Action 2007/02/02 MDCO Ref. No. Description of Product Cyberonics VNS Therapy System, Model 250-'HAND HELD' programming software v6.1, v6.1.7, v7.0, v7.1.3 & 2500SA070201 'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0, v7 1 3 Maquet - Jostra Heater Cooler Unit HCU30, System version 1.02SA070202 Low voltage machin, Article no.: 0704629 (serial no. 101006 101024) SA070203 SA070207 SA070209 GE Centricity PACS RA 1000 Workstation (Version 2.1.X.X. and 3.0.X.X.) SA070210 Bio-Rad D-10 Dual Program Calibrator Diluent SA070211 Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile REF FUS-095013-DL SA070212 SypGlassT Lightcable, SypGlassT Camera, SpyGlass T Ocular and Boston Scientific (HK) SpyGlassT Probe Ltd SA070213 Heartsine Technologies Ltd - Defibrillators, Non implantable Samaritan AED Models SAM-001, SAM-002 and SAM-003 MHRA 2006/011/006/291/015 Field Safety Corrective Action SA070214 BOC Ltd - AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units MHRA MDA/2007/011 MHRA (1) Cook Asia (Hong Kong) Ltd. (2) (1) 2781 0232; (2) A.R. Burkhill & Sons (Hong Kong) Ltd. 2541 1041 Boston Scientific 2960 7128 2007/02/05 N/A N/A Medical Device Alert 2007/02/06 BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO) 2372 2288 MDA/2007/013 Medical Device Alert 2007/02/07 Medtronic International, Ltd. 2919 1362 MHRA 2007/001/031/121/003 Field Safety Corrective Action 2007/02/07 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set Health Canada 33352 Type II 2007/02/07 Varian Medical Systems Pacific Inc. 2724 2836 SA070218 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/7) Health Canada 32880 Type II 2007/02/07 Sanko Medical System (HK) Ltd 2384 0688 SA070219 Walter Lorenz- 2" QC Solid Shaft Extention Health Canada 33542 Type II 2007/02/07 N/A N/A Spacelabs Medical - Ultraview SL Command Module SA070220 (Model/Catalog#91496) Health Canada 33638 Type II 2007/02/07 Schmidt BioMed Tech (HK) Ltd 2620 8310 Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd GE Healthcare - Computed tomography - LightSpeed VCT SA070216 Discovery VCT - LightSpeed Pro32 - LightSpeed Pro 16 LightSpeed RT16/ LightSpeed Xtra SA070215 Medical Device Control Office N/A 2393 9511 95 Department of Health The Government of HKSAR SA070221 GE Healthcare - Innova 2100 IQ Health Canada 33717 Type II 2007/02/07 GE Medical Systems Hong Kong Ltd. SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits Health Canada 33803 Type II 2007/02/07 Tokibo Co. (Hong Kong) Ltd 2783 1838 2418 9698 SA070223 Tyco Healthcare- CT9000 ADV with Console Biomerieux - Vironostika HIV-1 Microelisa System SA070224 (Model/Catalog#259605; Lot/Serial#160354) SA070225 Misys Healthcare System Version 6.1 and 6.2 Health Canada 33834 Type II 2007/02/07 Tyco Healthcare (HKSAR) Limited 3157 7244 Health Canada 33570 Type I 2007/02/07 Biomerieux (Hong Kong) 2356 7033 Health Canada 32993 Type II 2007/02/07 N/A N/A VISX Incorporated - Wavescan Wavefront System (Model/Catalog SA070226 HS-1) Health Canada 33201 Type II 2007/02/07 VISX Incorporated (HK) N/A Dentalez Inc. Stardental Division - Solara Replacement Turbine SA070227 (Model/Catalog#263739, Lot#170510) Health Canada 33350 Type II 2007/02/07 N/A N/A SA070228 Siemens AG - Magneton Trio (Model: 7387074) Health Canada 33837 Type II 2007/02/07 Siemens Ltd. 2870 7533 Health Canada 33121 Type II 2007/02/07 Sanko Medical System (HK) Ltd 2384 0688 SA070229 Toshiba - Digital Fluorography System (Model or Catalog # DFP8000D) SA070230 Terumo Advance Perfusion System 1 Integrated Centrifugal System Control Unit (Catalog#801046) FDA Z-0381-2007 Class II 2007/02/08 Terumo China (H.K.) Ltd. 2866 0811 SA070231 Bard Peripheral Vascular Inc - G2 Filter System Jugular/Subclavian Delivery kit (Catalog# RF-320J & RF-220J) FDA Z-0393-2007 to Z-0394-2007 Class II 2007/02/08 N/A N/A SA070232 Davol Salute Fixation System 38cm and 18cm Resusable Shaft with Handle (Ref#113036/9113036 and 0113037/9113037) FDA Z-0374-2007 to Z-0375-2007 Class II 2007/02/08 N/A N/A SA070233 Rhytec, Inc - Portrait PSR3 System FDA Z-0397-2007 Class II 2007/02/08 N/A N/A Custom Ultrasonics Inc - Stop manufacturing and distributing SA070234 System 83 Plus Water/Disinfector and System Plus 83 Mini-Flex Washer/Disinfector FDA N/A Press Release 2007/02/08 N/A N/A SA070235 Baxter Healthcare - Amicus Apheresis Kits F4R2337 (Lot#A06129053) MHRA 2007/002/005/291/011 Field Safety Corrective Action 2007/02/08 Baxter Healthcare Ltd 2807 8556 SA070236 Boston Scientific - Urgent Medical Device Recall - Immediate Action Boston Scientific (HK) Required: Matrix 2 Ltd Firm Initiated Field Action Field Safety Corrective Action 2007/02/09 Boston Scientific (HK) Ltd 2960 7128 SA070237 Medtronic - Spinal Implants - Colorado 2 Anterior Plates # 8639500 & #8619500 MHRA 2007/002/006/291/007 Field Safety Corrective Action 2007/02/12 Medtronic International Ltd 2919 1362 SA070238 Abbott - StarClose Vascular Closure System (Catalogue# 14677; Lot # 43034-6H to 47139-6H) MHRA 2007/002/005/081/014 Field Safety Corrective Action 2007/02/12 Abbott Laboratories Ltd. 2806 4201 SA070239 Bayer - Benzodiazepine Reagent Lot 56510483 used with ADVIA 1200, 1650, 1800 and 2400 Chemistry System MHRA 2007/001/015/081/013 Field Safety Corrective Action 2007/02/12 Bayer Healthcare Ltd (Hong Kong) 2814 4829 SA070240 Smiths Medical Level 1 normothermic IV Fluid administration set (Catalogue # DI-60HL) (NHS Supply Chain code FFF265) MHRA MDA/2007/015 Medical Device Alert 2007/02/13 Smiths Medical (S.E. Asia) Ltd. 2317 0988 MHRA MDA/2007/016 Medical Device Alert 2007/02/13 Direct Health Ltd 2528 1109 MHRA 2007/002/001/081/008 Field Safety Corrective Action 2007/02/14 Medtronic International Ltd 2919 1362 FDA Z-0415-2007 to Z-0416-2007 Class II 2007/02/15 Abbott Laboratories Ltd. 2806 4201 FDA Z-0399-2007 to Z-0400-2007 Class II 2007/02/15 Stryker China Ltd 2518 6988 FDA Z-0418-2007 to Z-0420-2007 Class II 2007/02/15 Beckman Coulter Hong Kong Ltd 2240 6260 SA070241 Invacare C800 Series ceiling track SA070242 Medtronic - Vitatron T and C pacemakers Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 & SA070243 3M74-01; Temp Controller Board Par#78560-109&7856-109) Stryker - Triathlon X3 CR Tibial Bearing Insert for Knee prosthesis SA070244 size # 2-11MM & 7-11MM (Ref# 5530-G-211 2011-09 & 5330-G711 2011-09) Cytomics FC500 and FC500 MPL with CXP Software version 2.0 & SA070245 2.1 Medical Device Control Office 96 Department of Health The Government of HKSAR SA070246 Perry-Kolberg Tiatanium Motility/Support System (Model 100045) (Lot# M-50021) FDA Z-0396-2007 Class II 2007/02/15 N/A N/A SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor MHRA MDA/2007/017 Medical Device Alert 2007/02/15 Welch Allyn N/A SA070248 Draeger Infinity monitor with Infinity docking station(IDS) MHRA MDA/2007/018 Medical Device Alert 2007/02/15 Draeger Medical Hong Kong Ltd. 2877 3077 SA070249 GE Healthcare - Ventilator - Engstom Ventilator MHRA 2007/002/008/601/579 2007/02/15 GE Medical Systems Hong Kong Ltd. 2783 1838 SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console MHRA 2007/002/005/081/012 2007/02/15 N/A N/A Field Safety Corrective Action Field Safety Corrective Action SA070251 Ascent Healthcare Solutions - AutoSuture Bladed Trocar (Model # 179094) FDA Z-0414-2007 Class II 2007/02/15 N/A N/A SA070252 Belcher Pharmaceuticals Inc - Mucotrol Conc. Oral Gel Wafer contained in HDPE Bottle FDA Z-0398-2007 Class II 2007/02/15 N/A N/A SA070253 Fisher and Paykel Healthcare - Cosycot Infant Warmer Health Canada 33376 Type II 2007/02/21 Tokibo Co. (Hong Kong) Ltd. 2418 9698 SA070254 Wilson-Cook Medical, Inc. - Quantum Biliary Dilation Balloon Health Canada 33986 Type II 2007/02/21 N/A N/A SA070255 Medex Inc. - Pressure Transducer Cartridge Health Canada 33633 Type II 2007/02/21 Smith Medical (S.E. Asia) Ltd. 23170988 Health Canada 33908 Type II 2007/02/21 Adaltis Healthcare (HK) Ltd 3123 8000 Type II 2007/02/21 Philips Electronics Hong Kong Ltd. 2876 7525 SA070256 Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B; Lot/Serial# 6770192, 6770192F) SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit Health Canada 33815 Resonant Medical Inc. - Restitu U/S Guide & Restitu U/S-SIM SA070258 (Model# 9100-00015-2 & 9100-00015-1) Health Canada 33905 Type II 2007/02/21 N/A N/A SA070259 Linvatec - E9000 Bur Products and Ultrapower Bur Products Health Canada 33634 Type II 2007/02/21 N/A N/A SA070260 Skytron - Infinity Series Surgical Lights Health Canada 33902 Type II 2007/02/21 N/A N/A Cardinal Health - Custom Sterile Cardiovascular Packs SA070261 (Model/Catalog#SCV30OHXXX, SCV30PCXXX) (Lot/Serial#769528, 781014, 778976, 787188) Health Canada 33870 Type II 2007/02/21 N/A N/A Health Canada 32633 Type II 2007/02/21 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 32382 Type II 2007/02/21 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 33595 Type II 2007/02/21 Johnson & Johnson Medical Hong Kong 2738 6162 2007/002/014/401/013 Field Safety Corrective Action 2007/02/21 N/A N/A 2007/02/21 Cemma Enterprise Co Ltd 2412 2310 2007/02/21 Smith & Nephew Healthcare Ltd. SA070262 GE Healthcare - Precision RX/I Fluoroscopic X-Ray System (Model/Catalog#S1303JJ/JK/JL/JM) GE Healthcare - Precision 500D (Model/Catalog#S0915KE, SA070263 S0915KF) Ortho- Clinical Diagnostics - Fetalscreen Test for D(RHO) Positive SA070264 Fetal Red Blood Cells (Model/Catalog#780540) (Recall#33595) Williams Medical Suppliers Plc - Comfisound (Code: D52208, SA070265 D52209, 69.2100) MHRA American medical System- AMS700 Penile Prosthesis (Part no: SA070266 72402987; Lot 475485004) MHRA 2007/002/015/081/004 Field Safety Corrective Action Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right SA070267 (Product codes: 71800508 & 71800513) (Lots# 06CM17723 & 06CN15086) MHRA 2007/001/016/081/012 Field Safety Corrective Action Candela - Vbeam/Aesthetica, Platiunum and Perfecta model laser SA070268 systems MHRA 2007/001/029/081/010 SA070269 Cardinal Health - Alaris Div -Syringe pumps (Signature Edition) MHRA 2006/008/029/081/009 Medical Device Control Office 97 Field Safety Corrective Action Field Safety Corrective Action 2645 8730 2007/02/21 N/A N/A 2007/02/21 N/A N/A Department of Health The Government of HKSAR Conmed DetachaTip endoscopic Multiple use grasper and SA070270 disposable hand held graspers and dissectors (Ratcheted and nonratcheted) SA070271 Durex Canada - Confirm Clearly Smart Pregnancy Test MHRA MDA/2007/019 Health Canada 34026 SA070272 SonoSite Inc (UK Rep) - LAP/12-5MHz Laparoscopic Transducer MHRA 2007/002/020/291/011 SA070273 Makro Medical - MAKROMED URINE TEST STRIPS - all models MHRA 2007/001/023/081/007 Medical Device Alert 2007/02/21 N/A N/A Type II 2007/02/21 SSL Healthcare Asia Ltd 2528 6778 2007/02/21 N/A N/A 2007/02/22 N/A N/A Field Safety Corrective Action Field Safety Corrective Action SA070274 Clearview Simplify D- Dimer( Product code 505285; Kit Lot numbers: PT030A & PT031A) MHRA 2007/002/020/291/014 Field Safety Corrective Action 2007/02/26 N/A N/A SA070275 Abbott - ARCHITECT FREE T3 Reagent (List # 7K63-20, 7K63-25, 7K63-30) MHRA 2007/002/019/601/608 Field Safety Corrective Action 2007/02/26 Abbott Laboratories Ltd. 2806 4201 SA070276 Intavent Orthofix Ltd - Flexible size 2.5 Laryngeal Masks (REF 7125R and 7125DR) MHRA 2007/002/013/081/009 Field Safety Corrective Action 2007/02/27 N/A N/A MHRA 2007/002/019/121/006 Field Safety Corrective Action 2007/02/27 N/A N/A Bausch & Lomb - TSV 25 Gauge High-Speed Cutter (Catalog no SA070277 CX5825) & TSV 25 Gauge High-Speed Posterior Vitectomy Pack (Catalog nos CX4925 & CX4925A) Medical Device Control Office 98 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - January 2007 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) Local Agent Agent Contact Telephone No. Terumo China (H.K.) Ltd. 2866 0811 N/A N/A N/A N/A SA070101 Terumo Advanced Perfusion System 1, Model 801763; Model 801764 FDA Z-0306-2007 & Z-307-2007 Class II 2007/01/03 SA070102 Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model No, 25-16-155BL FDA Z-0309-2007 & Z-310-2007 Class II 2007/01/03 SA070103 Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part no, 064900 FDA Z-0313-2007 Class II 2007/01/03 SA070104 Terumo Advanced Perfusion System 1, Model 801763; Model 801764 FDA Z-0314-2007 & Z-0315-2007 Class II 2007/01/03 Terumo China (H.K.) Ltd. 2866 0811 FDA Z-0316-2007 Class II 2007/01/03 N/A N/A SA070106 Sorin Group Venous Femoral Catheter Wire Reinforced MHRA 2006/012/012/081/008 2007/01/04 N/A N/A Siemens Medical Solutions Mammomat 1000 and Mammomat SA070107 3000/Nova MHRA 2007/001/003/081/001 2007/01/04 Siemens Ltd. 2870 7533 Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, Posterior Acetabular Retrator-Right with Light Cord SA070105 Bracket, Model #BIO-1-1050-A, packaged 1 retractor (left or right retractor) per plastic bag MHRA 2006/010/023/601/367 SA070109 Siemens AG Magicsas/Sienet IWM Health Canada 33372 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Type II Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot SA070110 1263830) Health Canada 33320 Type II SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys 2007/01/04 GE Medical Systems Hong Kong Ltd. 2783 1838 2007/01/08 Siemens Ltd. 2870 7533 2007/01/08 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Johnson & Johnson Medical Hong Kong 2738 6080 SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips FDA Z-0266-2007 Class I 2007/01/10 SA070112 SA070113 SA070114 SA070115 FDA FDA FDA FDA Z-0292-2007 & Z-0293-2007 Z-0308-2007 Z-0322-2007 & Z-0337-2007 Class I Class II Class II Class II 2007/01/10 2007/01/10 2007/01/10 2007/01/10 Terumo China (H.K.) Ltd. Philips Electronics Hong Kong Ltd. Terumo China (H.K.) Ltd. 2866 0811 2876 7525 2866 0811 FDA Z-0338-2007 Class II 2007/01/10 N/A N/A FDA Z-0339-2007 Class II 2007/01/10 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Smith & Nephew Trufit CB Plug Size Codes: Red, 7mm (Part #605SA070118 001-03, Blue, 9mm (Part #605-001-05); TruFit BGS Plug Size Code Red, 7mm (Part #600-001-03), Blue 9mm (Part#600-001-05) FDA Z-0440-2007 to Z-0443-2007 Class II 2007/01/10 Smith & Nephew Healthcare Ltd. Puritan Bennett KngithStar 330 Bi-Level Ventilator, Catalogue No. SA070119 Y-KS330-NA. Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLYKS330-NA & DLY-KS330-SD FDA Z-044-2007 Class II 2007/01/10 Tyco Healthcare (HKSAR) Limited 3157 7244 Bard Composix Kugel Large Sized Patches Terumo Advanced Perfusion System 1, Model 801041; Model Philips Medical Systems HeatStart FR2+ Defibrillator, Terumo Advanced Perfusion System 1 Edwards LifeSciences-Swan-Ganz, Thermodilution Venous Infusion SA070116 Port(VIP) Catheter with AMC Throboshield (An Antimicrobial *Heparin Coating), Ref: 831HF75, Model 831FH75 SA070117 Smiths Medical ASD Inc. Bivona Laryngectomy Tube, ID 8.5mm, O.D. 11mm Length 88mm, TTS 11.8mm 2645 8703 SA070120 Bayer Advia 70 Hematology Analyzer, Drew Excell 22 Hematology Analyzer FDA Z-0448-2007 & Z-0449-2007 Class II 2007/01/10 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 SA070121 Abbott Laboratories, Inc. Phenobarbital-Reagent-Clinical Chemistry, List no. 1E08-20 FDA Z-0454-2007 Class II 2007/01/10 Abbott Laboratories Ltd. 2806 4201 Medical Device Control Office 99 Department of Health The Government of HKSAR SA070122 Integra LifeSciences BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog No. 159004ND SA070123 Shenzhen Bestman Instrument Media Injectors (X-ray) contrast medium syringe SA070124 Corybros Ltd - CB3600 Select lots of O2Optix (lotrafilcon B) Soft Contact Lenses. The lots affected in this recall are all lots numbers starting with 6644001 to 6721262 with expiration dates starting from 2011/09 to 2011/11, SA070125 and lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, and 6643080, all with expiration dating of 2011/08. SA070126 Stryker - Howmedica Hip Fracture Stem System FDA Z-0466-2007 Class II 2007/01/10 N/A N/A MHRA 2006/011/022/401/015 Field Safety Corrective Action 2007/01/10 N/A N/A MHRA 2006/010/002/601/324 Field Safety Corrective Action 2007/01/10 N/A N/A Health Canada 33715 Type II 2007/01/16 CIBA Vision (Hong Kong) Ltd. 2814 2121 FDA Z-0472-2007 to Z-0476-2007 Class II 2007/01/17 STRYKER CHINA LTD 2518 6988 SA070127 SPS Blue Line Tube Clamp Adapters, Product number BL120M FDA Z-0445-2007 Class II 2007/01/17 N/A N/A Viasys V.P.I. Bird Gold pediatric ventilator, catalog no. 15653 and SA070128 15654 FDA Z-0480-2007 to Z-0481-2007 Class II 2007/01/17 Viasys Healthcare Hong Kong Ltd Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part SA070129 #700.08310-24' and Part #700.08320-36') FDA Z-0482-2007 Class II 2007/01/17 Arjo Far East Ltd (Hong Kong) 2508 9553 FDA Z-0486-2007 Class II 2007/01/17 Socofar Ltd 2861 3261 Ossur - Re-Flex VSP and Low Profile Re-Flex VSP external SA070130 prosthetic foot modules (Model no.: RFXS0002, RFXS0003, RFLS0006 and RFL50007 SA070131 Stryker - Simplex P with Tobramycin Anitibiotic PMMA Bone FDA Z-0467-2007 Class II 2007/01/17 STRYKER CHINA LTD 2518 6988 FDA Z-0486-2007 to Z-0487-2007 Class II 2007/01/17 N/A N/A FDA Z-0483-2007 to Z-0484-2007 Class II 2007/01/17 Baxter Healthcare Ltd 2807 8517 Medtronic International, Ltd. N/A N/A 2007/01/22 Medtronic International, Ltd. 2919 1362 SA070135 Toshiba - Xario Main Unit (Model # SSA-660A) Health Canada 32878 and 33122 Type II 2007/01/22 Sanko Medical System (HK) Ltd 2384 0688 Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070136 8000D) Health Canada 33123 Type II 2007/01/22 Sanko Medical System (HK) Ltd 2384 0688 SA070132 Varian Medical Systems GammaMed 12i and 12t radionuclide applicator systems Baxter Colleague Single and Triple Channel Volumetric Infusion SA070133 Pumps (Product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R) Medtronic - Voluntary Field Corrective Action of Reliant Stent Graft SA070134 Balloon Catheter and Talent Coiltrac AAA Stent Graft Delivery System with Balloon. SA070137 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/DC and TSX-101A/8) Health Canada 32870 Type II 2007/01/22 Sanko Medical System (HK) Ltd 2384 0688 SA070138 Toshiba - X-Rays High Voltage Generator Health Canada 33118 Type II 2007/01/22 Sanko Medical System (HK) Ltd 2384 0688 Inverness Medical Professional Diagnostics - Clearview HCG SA070139 Combo (Model or Catalog # 6026KCV) Health Canada 32452 Type II 2007/01/22 Nordep Healthtech 2881 7871 SA070140 Inverness Medical Professional Diagnostics - Clearview HCG Combo (Model or Catalog # 6026KCV) Health Canada 32607 Type II 2007/01/22 Nordep Healthtech 2881 7871 SA070141 Philips Medical System- Allura XPER FD10 and Allura XPER FD20/10 System, Main Unit Health Canada 33501 Type II 2007/01/22 Philips Electronics Hong Kong Ltd. 2876 7525 Health Canada Health Canada 32189 33251 Type II Type II 2007/01/22 2007/01/22 Johnson & Johnson Medical Hong JOINHANDS TECH LTD 2738 2818 2635 3455 SA070142 Cordis Prowler Infusion Catheter SA070143 Baylis Medical Company, Inc. - Baylis RF Cannula Draeger Medical - Medical Air Compressor (Model or SA070144 Catalog#8413419) SA070145 Alsius Corp. - Cool Line Catheter Model CL-2295AE Medical Device Control Office Health Canada 33587 Type II 2007/01/22 Draeger Medical Hong Kong Ltd. 2877 3077 Health Canada 33400 Type II 2007/01/22 N/A N/A 100 Department of Health The Government of HKSAR Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2) R2 and Immunoglobulin G (IGGT) Assay Health Canada 32922 Type II 2007/01/22 Roche Diagnostics (Hong Kong) Limited 2485 7510 SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100 Health Canada 33046 Type II 2007/01/22 GE Medical Systems Hong Kong Ltd. 2783 1838 I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or SA070148 Catalog#PM012 )(Lot or Serial # 662449, 662742) Health Canada 33058 Type I 2007/01/22 N/A N/A Health Canada 33211 Type I 2007/01/22 N/A N/A MHRA 2006/012/021/601/481 Field Safety Corrective Action 2007/01/22 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 33497 Type II 2007/01/22 N/A N/A SA070146 SA070149 Airox Legendair Ventilator (Lot or Serial# All Airox Legendair Ventilator LE030007, EXPECT LE020007, LE021009) SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting SA070151 Balloon SA070152 BOC Ltd - AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units MHRA MDA/2007/007 Medical Device Alert 2007/01/25 BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO) 2372 2288 SA070153 Beckman Coulter - Access Immunoassay System CEA (Part no 33200) (Lot no.: ALL) MHRA 2006/004/027/121/008 Field Safety Corrective Action 2007/01/25 Beckman Coulter Hong Kong Ltd. 2240 6260 MHRA 2007/001/008/081/007 Field Safety Corrective Action 2007/01/25 Varian Medical Systems Pacific Inc. 2724 2836 Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry Systems, SA070155 Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests FDA Z-0351-2007 to Z-0353-2007 Class II 2007/01/25 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 SA070154 Varian Medical - On Board Imager CBCT SA070156 Abbott Spine TraXis Fixed Trail and TraXis Fixed Rasp FDA Z-0354-2007 to Z-0355-2007 Class II 2007/01/25 Abbott Laboratories Ltd. 2806 4841 SA070157 Embeem Inc - HiZel, Trayless-sterile hydrogel wound dressing FDA Z-0455-2007 Class II 2007/01/25 N/A N/A Rymed Technologies, Inc. - RYM-5000 & RYM-5001 InVision-Plus SA070158 Neutral Displacement and RYM-5000 InVision-Plus NEUTRAL I.V. Connector FDA Z-0319-2007 to Z-0321-2007 Class II 2007/01/25 N/A N/A Continental Medical Labs, Inc. -Fibrin Analysis Catheter Testing SA070159 System includes the component BD Vacutainer Luer-Lok Access Device (Catalog#364902) FDA Z-0357-2007 Class II 2007/01/25 N/A N/A Boston Scientific (HK) Ltd N/A Firm Initiated Field Action 2007/01/26 Boston Scientific (HK) Ltd 2960 7128 MHRA MDA/2007/2008 Medical Device Alert 2007/01/30 N/A N/A MHRA 2006/007/027/401/003 Field Safety Corrective Action 2007/01/30 N/A N/A SA070160 Boston Scientific - HTA System SA070161 Draeger Medical - Neonatal radiant warmer: Draeger Resuscitaire model RW82VHA-1C with variable height adjustment Unomedical Ltd - Cord Clamps: Cutter-umbilical cord clamp clipper SA070162 (lot#102042/118351/121457/134481/136591/142538/146675/15116 8/155746) SA070163 Hemo Cue Ltd - HemoCue Glucose 201 and HemoCue Glucose 201RT instruments MHRA 2007/001/015/081/014 Field Safety Corrective Action 2007/01/30 Science International Corp 2543 7442 SA070164 Siemens Diagnostics - IMMULITE 2000/2005 Chartable Report Used with SMS MHRA 2007/001/023/601/530 Field Safety Corrective Action 2007/01/31 Siemens Ltd. 2870 7533 Medical Device Control Office 101 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - December 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Date of Issue (YYYY/MM/DD) BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human CD16 SA061201 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04 Monoclonal Antibody, Clone 3G8, Cat. No. 555403, lot # 43033 BD Pharmingen PE-Conjugated Mouse Anti-Human Fetal Hemoglobin SA061202 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04 Monoclonal Antibody, Clone 2D12, Cat. No. 551797, lot # 38377 SA061203 SA061218 Baxter Health Flo-Gard 6200, 6201, 6300 & 6301 Depuy Int. (J&J) Preservation Uni-Compartmental Knee size 3 Fixed bearing Tibial Tray Boston Scientific iLab Ultrasound Imaging System, Installed Models iLab120INS and iLab240INS Lone Star Medical Products 1100 Series Aluminum Retractor Rings, Models #1104, 1107 and 1110 Nihon Kohden Electric Stimulator, Model number: MS-210BK, Any serial numbers up to 02160 Computerized Medical Systems AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit, Product Code: 852-00, Lot Number: 024448 Data Innovations Roche Modular Drive (rchmdlri) and Roche Cobas driver (rchcob6i) analytical laboratory data interface, various software Dentsply Friadent XiVE S plus Screw Implant D3.0/L11, D3.0/L13 and D3.0/L15 dental implants Cory Brothers Ltd. MPC SCT/50/6 Suctioni Tubing Abbott Molecular Inc. RealTime CT/NG assay and RealTime CT assay List Number 2G28 and 1L31 TomoTherapy Incorporated HI-ART System H-0000, H-0000-0001 Kavo Dental Quattrocare spray can Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent Implantation System Innovatek Medical Quickstick HCG Pregnancy Test Kit, Model or Catalog # 4220-4K, Lot or Serial # 5-09076 Toshiba Medical Systems Aquilion CT Scanner, Model or Catalog # SA061219 Philips Brilliance CT Big Bore System, Lot or Serial # 7062 and 7017 SA061204 SA061205 SA061206 SA061207 SA061208 SA061209 SA061210 SA061211 SA061212 SA061213 SA061214 SA061215 SA061216 SA061217 MHRA 2006/011/030/291/010 FSCA 2006/12/04 MHRA 2006/011/022/081/001 FSCA 2006/12/04 Firm Initiated Field Action 2006/12/06 Boston Scientific H. K. Ltd. FDA Z-0218-2007 Class II FDA Z-0221-2007 Class II 2006/12/06 FDA Z-0222-2007 Class II 2006/12/06 FDA Z-0223-2007 & Z-0224-2007 Class II 2006/12/06 FDA Z-0230-2007 to Z-0232-2007 Class II 2006/12/06 SA061226 SA061227 SA061228 SA061229 SA061230 SA061231 SA061232 SA061233 SA061234 SA061235 SA061236 Medical Device Control Office 2575 8668 The local agent informed all affected users. Baxter Healthcare Ltd. Johnson & Johnson Medical Hong Kong 2807 8556 The local agent informed all affected users. Boston Scientific H. K. Ltd. 2960 7117 Data Innovations Asia 2398 3182 2738 2818 The local agent informed that no affected units had been distributed in Hong Kong. 2006/12/06 2006/12/06 2006/011/030/601/437 FSCA 2006/12/06 Abbott Laboratories Ltd. 2806 4841 The local agent informed that no affected units had been distributed in Hong Kong. MHRA MHRA 2006/011/015/291/006 2006/012/007/081/004 FSCA FSCA 2006/12/06 2006/12/08 Interdental Ltd. 2541 1096 The local agent informed all affected users. MHRA 2006/012/005/601/444 FSCA 2006/12/08 Sanko Medical Systems (H.K.) Philips Electronics Hong Kong Ltd. Medisource Supply (Asia) Co. Ltd. Philips Electronics Hong Kong Philips Electronics Hong Kong Ltd. 2384 0688 Health Canada Recall # 32712 Type II 2006/12/11 Health Canada Recall # 31601 Type II 2006/12/11 Health Canada Recall # 32814 Type II 2006/12/11 Recall # 32787 Type II 2006/12/11 Recall # 32826 Type II 2006/12/11 Recall # 32827 Type II 2006/12/11 Recall # 32662 Type II 2006/12/11 Recall # 32817 Firm Initiated/Type III 2006/12/11 Recall # 32928 Type II 2006/12/11 Recall # 30550 Type II Recall # 32953 Type II 2006/012/007/601/454 Z-0228-2007 Z-0244-2007 Z-0247-2007 Z-0248-2007 / Z-0249-2007 William Cook Europe Flexor Check-Flo Micropuncture Radial Artery Access Introducer Sets with AQ Hydrophilic Coating SA061225 Becton Dickinson Asia Ltd. MHRA SA061240 SA061224 The local agent informed that no affected units had been distributed in Hong Kong. Action Boston Scientific Katzen infusion wires SA061223 2575 8668 MDA/2006/067 SA061239 SA061222 Becton Dickinson Asia Ltd. MHRA SA061237 SA061238 SA061221 Agent Contact Telephone No. 2006/12/06 FDA Conmed Soft Tip Frazier, Frazier Surgical Suction Instrument and Poole Health Canada Suction Instrument Health Canada Philips Ultrasound IE33 Diagnostic Ultrasound Transducer, Identifier Philips Medical Systems Gemini GXL 6/10/16 Slice Pet/CT System, lot Health Canada or serial # 882410 Health Canada Medi-Inn Swabette, model or catalog # MIS300 and MIS401 LifeScan OneTouch Ultrasmart Blood Glucose Meter, model or catalog LifeScan Ltd. # 020-720 and 020-721 with serial numbers starting with TC, TD, TF or Health Canada Unomedical A/S Cord Clamp Clipper, Serial # M3186023572, Lot # Toshiba Medical Systems Digital Fluorography System, Model or Health Canada Catalog # DFP-8000D and DFP-8000D/FPD Bio-Rad Laboratories Diagnostics D-10 Haemoglobin Testing System Health Canada Dual Program, model or catalog # 220-0201 Medtronic Precision Plus Transurethral Needle Ablation (TUNA) therapy Medtronic International, Ltd. system, model 7900 MHRA Abbott Diagnostics Architect LH Reagent FDA Accumetrics Inc. Verify Now P2Y12 Assay Device Kit, Part No. 85054 FDA Teleflex Medical Neoprene Pecan Shaped Breathing Bag Dade Behring Brand MicroScan Prompt Inoculation System-D; Catalog FDA #B1026-10D FDA Arjo Inc. Sling Rope/Connector Asembly Kits Boston Scientific 1cm peripheral cutting balloon microsurgical dilatation Boston Scientific H. K. Ltd. devices MHRA Fisher and Paykel Healthcare Ltd (NZ) Acclaim HC401 Nasal Mask Fisher and Paykel Healthcare Ltd (NZ) All Single Use Heated Breathing MHRA Circuits Arcomed Administration Set-3101-LPPJ MHRA Boston Scientific H. K. Ltd. Boston Scientific Hemashield vascular grafts and fabrics SA061220 Z-0212-2007 to Z-0214-2007 Class II Remarks Local Agent 2006/011/023/081/004 2145 4442 2821 5480 Johnson & Johnson Medical Hong Kong 2738 6080 The local agent informed that no affected units had been distributed in Hong Kong. 2006/12/11 Sanko Medical Systems (H.K.) Ltd. 2384 0688 The local agent informed that no affected units had been distributed in Hong Kong. 2006/12/11 Bio-Rad Pacific Ltd. 2789 3300 Firm Initiated Field Action 2006/12/11 Medtronic International, Ltd. 2919 1362 FSCA Class II Class II 2006/12/11 2006/12/13 2006/12/13 Abbott Laboratories Ltd. 2806 4841 Class II 2006/12/13 Dade Behring Hong Kong Ltd 2803 0118 Class II 2006/12/13 Arjo Far East Limited 2508 9553 Firm Initiated Field Action 2006/12/13 Boston Scientific H. K. Ltd. 2960 7117 FSCA 2006/12/13 Tokibo Co. (Hong Kong) Ltd. 2418 9698 2006/012/013/291/005 FSCA 2006/12/13 Tokibo Co. (Hong Kong) Ltd. 2418 9698 FSCA Firm Initiated Field Action 2006/12/14 2006/12/15 Boston Scientific H. K. Ltd. 2960 7117 Firm Initiated Field Action 2006/12/15 Boston Scientific H. K. Ltd. 2960 7117 Action 2006/12/18 MDA/2006/071 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2876 7525 2006/012/012/601/458 Boston Scientific H. K. Ltd. MHRA 2821 5480 102 The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of the HKSAR SA061241 SA061242 Lombard Medical - Bifurcated Endovascular Graft Aorfix II Inditherm Heating Mattress SA061243 Boston Scientific Mach 1 guide catheters Boston Scientific H. K. Ltd. SA061244 Medtronic Rocker Reducer instruments Medtronic International, Ltd. SA061245 Biosense Webster Europe Preface Guiding Sheath MHRA 2006/011/023/291/013 SA061246 Guidant Ltd. Acrobat Vacuum Stabilizer System MHRA SA061247 SA061248 Femcare-Nikomed Ltd. Femcare Camera Sleeve Medtronic LIFEPAK 20 Defibrillator/Monitors Smiths Medical International CADD-Legacy PLUS and CADD-Legacy 2 Ambulatory Infusion Pumps -21-6400 & 21-6500 MHRA Medtronic International, Ltd. SA061249 SA061250 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips MHRA MHRA FSCA FSCA 2006/12/15 2006/12/18 Firm Initiated Field Action 2006/12/19 Boston Scientific H. K. Ltd. 2960 7117 Firm Initiated Field Action 2006/12/19 Medtronic International, Ltd. 2919 1362 FSCA 2006/12/18 2006/012/007/081/002 FSCA 2006/12/18 Guidant Hong Kong Ltd. 2593 2235 2006/012/018/291/025 FSCA Firm Initiated Field Action 2006/12/19 2006/12/20 Medtronic International, Ltd. 2919 1362 The local agent informed all affected users. MHRA 2006/002/015/291/004 FSCA 2006/12/20 Smiths Medical (S.E. Asia) Ltd. 2317 0988 The local agent informed all affected users. FDA Z-0206-2007 / Z-0207-2007 Class I 2006/12/20 Johnson & Johnson Medical Hong Kong 2738 2818 Z-0148-2007 Class II 2006/12/20 AMO Asia Ltd. 2401 5861 Z-0233-2007 to Z-0242-2007 Class II 2006/12/20 Terumo China (H.K.) Ltd. 2866 0811 2006/12/20 Becton Dickinson Asia Ltd. 2575 8668 AMO Asia Ltd. 2401 5861 The local agent informed that no affected units had been distributed in Hong Kong. Gambro China Ltd. 2576 2688 The local agent informed that no affected units had been distributed in Hong Kong. SA061251 AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses FDA SA061252 Terumo Cardiovascular Systems Terumo Perfusion System BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile FDA SA061253 FDA 2006/012/014/081/002 2006/011/024/401/010 Z-0253-2007 Class II The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. SA061254 AMO PhacoFlex II Model SI40NB Intraocular Lenses FDA Z-0267-2007 Class II 2006/12/20 SA061255 Medline Industries Medline Premium Wet Shin Prep Tray FDA Z-0268-2007 Class II 2006/12/20 SA061256 Gambro Lundia AB (Monitor Division) CWP100 MHRA 2006/008/017/081/001 FSCA 2006/12/20 SA061257 Biodiagnostics Ltd. Crithidia Luciliae Slides - Catalogue no. L058 / L108 Roche Diagnostics Cobas Taqman CT test, Amplicor Chlamydia Trachomatis Detection Kit, Amplicor Chlamydia MHRA 2006/012/004/601/443 FSCA 2006/12/21 MHRA 2006/011/024/081/004 FSCA 2006/12/21 Roche Diagnostics (Hong Kong) Limited 2485 7555 Invacare Spectra Plus Powered Wheelchair MHRA 2004/011/004/151/010 FSCA 2006/12/21 Direct Health Ltd. 2528 1109 The local agent informed that no affected units had been distributed in Hong Kong. SA061258 SA061259 Boston Scientific Wallstent endoscopic biliary endoprosthesis with Unistep Plus delivery system B Braun Aesculap Metha Modular short Stem Prosthesis BD Mini Blade Firm Initiated Field Action 2006/12/22 Boston Scientific H. K. Ltd. 2960 7117 The local agent informed all affected users. SA061261 SA061262 MHRA Becton Dickinson Asia Ltd. 2006/011/023/081/010 FSCA 2006/12/21 2006/12/28 2277 6125 2575 8668 The local agent informed all affected users. SA061263 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips FDA Z-0261-2007 & Z-0262-2007 Class I 2006/12/27 2738 2818 The local agent informed all affected users. SA061264 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips FDA Z-0263-2007 Class I 2006/12/27 B. Braun Medical (Hong Kong) Becton Dickinson Asia Ltd. Johnson & Johnson Medical Hong Kong Johnson & Johnson Medical Hong Kong 2738 2818 The local agent informed all affected users. FDA Z-0258-2007 & Z0259-2007 Class II 2006/12/27 Ultronics Enterprise Ltd. 2764 5208 Z-0269-2007 Class II 2006/12/27 Boston Scientific H. K. Ltd. 2960 7117 Z-0270-2007 to Z-0287-2007 Class II 2006/12/27 SA061260 SA061276 Medrad Invasive Blood Pressure Interface Cables (Part #3006314, 3008772 & 3010478) Guidant Contak REnewal 3 RF, 3 RF HE, 4 RF & 4 RF HE cardiac resynchronization therapy defibrillator Arrow Implantable Vascular Access System - Infusion Ports with Silicone Rubber Catheter Maillinckrodt OptiVantage DH Power Injection System Draeger Medical Infinity Docking Station (IDS) Delta and Kappa Patient Monitors. Model Nos. 4715319, 5206110 and 7489375 Datex Ohmeda Compact Absorber, Disposable REF 427002100, white to violet and REF 427002000 Terumo Advanced Perfusion System 1 Electonic Oxygen Blender/Analyzerl Catalog No. 801188 Maquet Critical Care AB HL30 Perfusion System Maquet Critical Care AB Jostra Heater-Cooler Unit 30 System Elekta Desktop Pro 6.0/6.1 Bio-Rad Laboratories Diagnostics Group Liquichek Cardiac Markers Control LT, Model 645, 645X, 646, 647, 648, 649, 649X Guidant ACS Rotating Hemostatic Valve SA061277 GE OEC Medical System, DBA GE Healthcare OEC 9900 SA061265 SA061266 SA061267 SA061268 SA061269 SA061270 SA061271 SA061272 SA061273 SA061274 SA061275 Boston Scientific H. K. Ltd. FDA FDA FDA Z-0288-2007 Class II 2006/12/27 FDA Z-0302-2007 Class II 2006/12/27 Draeger Medical Hong Kong Ltd. 2877 3077 FDA Z-0291-2007 Class II 2006/12/27 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-0294-2007 Class II 2006/12/27 Terumo China (H.K.) Ltd. 2866 0811 Health Canada Health Canada Health Canada Recall # 33015 Recall # 33014 Recall # 32786 Type II Type II Type II 2006/12/27 2006/12/27 2006/12/27 Maquet Hong Kong Limited Maquet Hong Kong Limited 2393 9511 2393 9511 Health Canada Recall # 33044 Type II 2006/12/27 Bio-Rad Pacific Ltd. 2272 8922 Health Canada Recall # 33048 Type II 2006/12/27 2593 2235 Health Canada Recall # 33053 Type III 2006/12/27 Guidant Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. 2783 1838 SA061278 Siemens Medical Solutions Linear Accelerators Health Canada Recall # 33065 Type III 2006/12/27 Siemens Ltd. 2870 7533 SA061279 SA061280 SA061281 Siemens AG Lithoskop Bausch & Lomb 20 Gauge High Speed Electric Vitrectomy Cutters SuperDimension Bronchus System Health Canada MHRA MHRA Recall # 33214 2006/012/015/081/007 2006/012/008/081/012 Type III FSCA FSCA 2006/12/27 2006/12/28 2006/12/28 Siemens Ltd. Bausch & Lomb (Hong Kong) 2870 7533 2213 3179 Medical Device Control Office 103 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of the HKSAR Monthly Summary of Medical Device Safety Alerts - November 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent Agent Contact (YYYY/MM/DD) No. Information* Telephone No. Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe SA060332 with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # FDA Z-0051-2007 Class II Recall 2006/11/01 Tyco Healthcare (HKSAR) Limited 2574 3251 888153744 GE ApexPro FH Telemetry System, Software versions v3.8 and GE Medical Systems Hong Kong SA060333 FDA Z-0054-2007 Class II Recall 2006/11/01 2783 1838 Ltd. earlier Depuy PFC Oval Dome Patella, Part Number 960100, Lot: Johnson & Johnson Medical Hong SA060334 FDA Z-0057-2007 Class II Recall 2006/11/01 2738 6080 2203528 Kong Cardinal Health Cardiovascular Split Drape II, various models SA060335 FDA Class II Recall 2006/11/01 N/A N/A Z-0058-2007 to Z-0062-2007 and lot numbers Siemens Medical Solutions Sienet Cosmos V15C, model SA060336 number 10018969, Serial numbers 1001, 1010, 1011, 1028, FDA Z-0069-2007 Class II Recall 2006/11/01 Siemens Ltd. 2870 7533 and 1029Medical Solutions Syngo Imaging, Sienet Sky and Siemens SA060337 Sienet Magic View 300 picture archiving and communications FDA Z-0070-2007 to Z-0072-2007 Class II Recall 2006/11/01 Siemens Ltd. 2870 7533 systems (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot FDA Z-0080-2007 Class II Recall 2006/11/01 A.R. Burkhill & Sons (Hong Kong) SA060338 1041 1722922 Ltd. Radiometer America Radiance Data Management System, SA060339 Software Version 2.60, modification for the ABL800 Flex Blood FDA Z-0115-2007 Class II Recall 2006/11/01 N/A N/A Gas Analyzer, Catalog Numbers: 914-418 and 914-426 Field Safety Corrective SA060340 Siemens MODULARIS Uro endourology tables MHRA 2006/010/010/291/005 2006/11/01 Siemens Ltd. 2870 7533 Action SA060341 Ferno Falcon Six stretcher trolleys Boston Scientific Mach 1 Peripheral Guide Catheter, lot # SA060342 575765 MHRA 2005/008/001/401/006 Boston Scientific H. K. Ltd. N/A SA060343 Welch Allyn Propaq LT patient monitors MHRA 2006/011/001/081/001 SA060344 Abbott CELL-DYN 22 calibrators and controls MHRA 2006/011/003/601/388 SA060345 Ansell Micro-Touch Nitrile examination gloves MHRA 2006/010/031/081/002 SA060346 Hardy Media HardyCHROM 0157, Catalogue Number G305, Lot numbers 06192 and 06235 SA060347 Venoscope Neonatal Transilluminator, Model NT01 Respironics REMstar Heated humidifier, model nos. 1007861, SA060327 R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive) Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2006/11/01 N/A N/A 2006/11/03 Boston Scientific H. K. Ltd. 2960 7117 2006/11/06 N/A N/A 2006/11/08 Abbott Laboratories Ltd. 2806 4201 2006/11/08 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Z-0078-2007 Class II Recall 2006/11/08 N/A N/A Class II Recall 2006/11/08 N/A N/A Respironics, Inc. N/A Urgent Medical Device Recall 2006/11/09 Celki Medical Company 2268 9229 With affected units in Hong Kong. 2006/11/09 Becton Dickinson Asia Ltd. 2575 8668 The local agent informed that no affected units had been distributed in Hong Kong. 2006/11/09 N/A N/A Field Safety Corrective Action Field Safety Corrective Action SA060349 Getinge steam sterilizers, various models Endologix Visiflex bifurcated Delivery Catheters, 155mm, used SA060350 for the Powerlink System (models 25-16-155BL and 28-16155BL) MHRA 2006/009/004/081/008 FDA N/A Firm Press Release 2006/11/09 N/A N/A SA060351 Toshiba Medical Systems Aquilion and Aquilion CFX Edition Health Canada 32674 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd. 2384 0688 SA060352 Toshiba Medical Systems Aquillion 16-Slice System Health Canada 32639 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd. 2384 0688 SA060353 Arjo Minstrel Lift with Scale Health Canada 32598 Type II Recall 2006/11/13 Arjo Far East Limited 2508 9553 Health Canada 32528 Type II Recall 2006/11/13 Agfa Hong Kong Ltd. 2555 9421 Health Canada 32627 Type II Recall 2006/11/13 N/A N/A Health Canada 32593 Type II Recall 2006/11/13 N/A N/A Health Canada 32498 Type II Recall 2006/11/13 Elekta Ltd. 2892 4320 Health Canada 32451 Type II Recall 2006/11/13 Draeger Medical Hong Kong Ltd. 2877 3077 Medical Device Control Office The local agents informed that no affected units had been distributed in Hong Kong. Z-0116-2007 2006/011/001/081/010 SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine The local agent informed that no affected units had been distributed in Hong Kong. FDA MHRA AGFA CR NX Modality Workstation, model or catalog # ES885, versions NX 1.0.2402 and NX 1.0.2405 Implant Innovations ITHA52 Certain EP Healing Abutment, Lot SA060355 or Serial # 560988 Calley & Currier Laminated Wooden Crutches, various models SA060328 and catalog numbers Elekta Instruments AB Leksell Gamma Knife C Version 1.2/4C, SA060356 Lot or Serial # 4310 and 4336 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. FDA SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745) SA060354 Remarks 104 The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR SA060358 Toshiba Medical Systems Opart MRI System SA060359 SA060360 SA060361 SA060362 SA060329 SA060363 SA060364 Immucor Panocell-16, 16 x 3ml, model or catalog # 0002332, lot or serial # 35411 Smith & Nephew Profix Hall 3/4 Fanned Sawblade, model or catalog # 71512903 Beckman Coulter EPOCS SL Flow Cytometers with EXPO 32 ADC Software Smiths Medical Level 1 D-60HK and DI-60HL Normothermic I.V. Fluid Administration Sets Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric soft (hydrophilic) contact lenses Enpath Medical pacemaker lead adapter and Angel Medical Systems Lead Adaptor system Hydrocision SpineJet XL MIS 20 and SpineJet XL MIS 30 degree Handpieces, Catalog Numbers 58662 and 58663 SA060365 DePuy Spine Bremer Halo System, various models Ortho-Clinical Diagnostics VITROS Chemistry Products GLU SA060366 DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box Hitachi Medical Systems Echelon Magnetic Resonance Imaging SA060367 System, Serial Number: V001 Precision Medical Easy Mate Portable Liquid Oxygen System SA060368 (container), PM22010 Series, Model number 2201, serial numbers P002892 through P005116 Access Point Medical Heavy Duty Rollators (rolling walker), SA060369 Product Codes: RL12010HD and RL12011 Lumiport DermaStyle Chroma 2-blue and red light device SA060370 indicated to be used in treating skin blemishes, portable home therapy SA060371 Maquet Jostra HL-20 Heart Lung Machine - guiding pins Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number W2243511 USA Instruments 1.5T HD Head Neck Spine Array (Model 2416329, for GE 1.5T Excite MR System) and 3.0T HD Head SA060373 Neck Spine Array (Model 2415545, for GE 3.0T Excite MR System) SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129 SA060372 Health Canada 32523 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd. 2384 0688 Health Canada 32531 Type II Recall 2006/11/13 Uninet Technology Ltd. 2838 8423 Type II Recall 2006/11/13 Smith & Nephew Healthcare Ltd. 2006/11/13 Beckman Coulter Hong Kong Ltd. 2240 6260 2006/11/14 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Health Canada 32280 MHRA 2006/011/010/291/002 MHRA 2006/011/009/081/009 FDA Z-0018-2007 to Z-0020-2007 Class II Recall 2006/11/15 Ciba Vision Hong Kong Ltd. 2814 2121 FDA Z-0120-2007 & Z-0121-2007 Class II Recall 2006/11/15 N/A N/A FDA Z-0123-2007 & Z-0124-2007 Class II Recall 2006/11/15 N/A N/A Z-0130-2007 to Z-0144-2007 Class II Recall 2006/11/15 2738 6080 The local agent informed all affected users. FDA Z-0151-2007 Class II Recall 2006/11/15 HealthCare Diagnostics Ltd. 2563 5193 The local agent informed all affected users. FDA Z-0152-2007 Class II Recall 2006/11/15 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-0153-2007 Class II Recall 2006/11/15 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-0154-2007 & Z-0155-2007 Class II Recall 2006/11/15 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-0156-2007 Class II Recall 2006/11/15 N/A N/A FDA Z-0159-2007 Class II Recall 2006/11/15 Maquet Hong Kong Limited 2393 9511 FDA Z-0160-2007 Class II Recall 2006/11/15 FDA Z-0163-2007 & Z-0164-2007 Class II Recall 2006/11/15 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. Becton Dickinson and Company (Japan) N/A Voluntary Recall 2006/11/15 Becton Dickinson Asia Ltd. 2575 8668 The local agent confirmed having no record of importing the affected devices into Hong Kong. 2006/11/15 Beckman Coulter Hong Kong Ltd. 2240 6260 2006/11/15 Draeger Medical Hong Kong Ltd. 2877 3077 2006/11/15 Onwon Trading Limited 2757 7569 2006/011/014/291/014 SA060375 Draeger Medical Infant Warmer - RW82VHA-1C MHRA 2005/005/025/401/001 SA060376 Novagen Ltd 2mm Angled Suction Tip MHRA 2006/011/010/401/006 MHRA 2006/011/013/081/007 Medtronic International, Ltd. N/A SA060379 Ferno Restraining straps/harness-Pedi-Mate 678 MHRA 2004/012/001/061/029 SA060380 Owen Mumford Unistik 3 Neonatal & Laboratory/Confort/Normal MHRA 2006/011/013/291/002 Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine SA060381 Therapy-LPD24 MHRA 2006/010/013/601/34 SA060382 Bard Access Systems HemoGlide Catheter Kits MHRA 2006/008/031/291/002 Medtronic SynchroMed® and IsoMed® Implantable Pain Infusion Pumps, various models Tyco Healthcare OptiVantage DH Contrast Media Injection SA060383 MHRA System Boston Scientific System Drape (IVUS motor drive sterile plastic Boston Scientific H. K. SA060384 cover), lot numbers M846990, M835770 and M844470 Ltd. Medical Device Control Office The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. FDA MHRA SA060378 2645 8703 Johnson & Johnson Medical Hong Kong Beckman Coulter Access Immunoassay Systems Thyroglobulin SA060374 Antibody SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays Field Safety Corrective Action Field Safety Corrective Action The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2006/011/014/081/008 N/A Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Important Patient Safety Management Information Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Medical Device Customer Notification 105 The local agent informed that no affected units had been distributed in Hong Kong. (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 The local agent informed that no affected units had been A.R. Burkhill & Sons (Hong Kong) 1041 distributed in Hong Kong. Ltd. 2006/11/16 N/A N/A 2006/11/17 Medtronic International, Ltd. 2919 1362 2006/11/17 N/A N/A 2006/11/20 N/A N/A 2006/11/20 N/A N/A 2006/11/20 N/A N/A 2006/11/20 Tyco Healthcare (HKSAR) Limited 2574 3251 2006/11/21 Boston Scientific H. K. Ltd. 2960 7117 The local agent informed all affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all affected users. Department of Health The Government of HKSAR Boston Scientific Jagwire High Performance Guidewire (lot # Boston Scientific H. K. SA060385 8887513) and Jagwire High Performance Extendable Guidewire Ltd. (lot # 8887514) N/A Urgent Medical Device Recall 2006/11/21 Boston Scientific H. K. Ltd. 2960 7117 Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE SA060331 Multi-Purpose Solutions, and COMPLETE MoisturePLUS MultiPurpose Solutions (Starter Kits) AMO Asia Limited N/A Voluntary Recall 2006/11/22 AMO Asia Limited 2401 5811 and 2401 5812 MHRA 2006/009/012/291/010 Field Safety Corrective Action 2006/11/21 Roche Diagnostics (Hong Kong) Limited 2485 7555 The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-0165-2007 & Z-0166-2007 Class II Recall 2006/11/22 Philips Electronics Hong Kong Ltd. 2821 5480 The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-0167-2007 Class II Recall 2006/11/22 Data Innovations Asia 2398 3182 FDA Z-0169-2007 Class II Recall 2006/11/22 Baxter Healthcare Ltd. 2807 8556 FDA Z-0170-2007 Class II Recall 2006/11/22 N/A N/A FDA Z-0182-2007 Class II Recall 2006/11/22 N/A N/A FDA Z-0183-2007 & Z-0184-2007 Class II Recall 2006/11/22 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-0185-2007 to Z-0188-2007 Class II Recall 2006/11/22 N/A N/A FDA Z-0189-2007 Class II Recall 2006/11/22 N/A N/A FDA Z-0190-2007 Class II Recall 2006/11/22 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 FDA Z-0193-2007 Class II Recall 2006/11/22 N/A N/A FDA Z-0195-2007 Class II Recall 2006/11/22 N/A N/A Health Canada 30937 Type II Recall 2006/11/27 N/A N/A Health Canada 32628 Type II Recall 2006/11/27 N/A N/A 2006/11/27 N/A N/A 2006/11/27 N/A N/A SA060386 Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus and CoaguChek Softclix single-patient self-testing lancing systems SA060387 Philips Allura X-per FD10/10 and FD20/10 X-ray and fluoroscopy systems Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, SA060388 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R) Baxter Meridian hemodialysis instruments, product codes SA060389 5M5576 and 5M5576R Bemis 5 Qt. Wallmount Sharps Container, Model 150, Regular SA060390 Size Olsen Medical MIDAS TOUCH Electrosurgical/102 mm (4 inch) SA060391 Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002 Philips Medical Systems M3001A Multi Measurement Server (MMS) and M1020B Pulse Oximetry Module Philips FAST Sp02 SA060392 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002 Sorenson Medical ambIT Ambulatory Infusion Pump Cassettes, SA060393 REF numbers 220139, 220140, 220266 and 220267, all serial numbers Eatonform Doc-U-Dose Prescription Management System, Item SA060394 8-PKIT, Carton numbers: 16 through 39 Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Lot SA060395 numbers: P031530, P031650, P040389, P040111, P051160, P051161 Trionix Research Laboratory BIAD Classic 24 (24 inch SA060396 collimator), Serial numbers B-102 through B-184 Ekos Lysus Transport Stand (infusion stand), part number SA060397 4896-003 Balt Extrusion Flow Dependent Micro-Catheter, models MAGIC SA060398 1.2FM, MAGIC MP and MAGIC STD Tornier Latitude Elbow Prosthesis Radial Head, models or SA060399 catalog # DKY056, DKY057, DKY058 and DKY059 SA060400 Rocket Medical Fetal Blood Sampling Kit Bard Ltd. Stone Basket - 042310, 042313, 042316, 043310, 043313, 043316 Elekta Instruments AB Leksell Gamma Knife, model or catalog SA060402 # 912800 SA060401 SA060403 Rocialle InHealth Sterile Procedure Pack - Basic Pack SA060404 SA060405 SA060406 SA060407 SA060408 SA060409 Abbott AxSYM Matrix Cells, Product List No: 8A73-02, Lot # 37618Q100 Plus Orthopedics UC-PLUS Solution Unicondylar Knee Systems Exactech Optetrak B-series cemented finned tibial tray, size 2f/2t, catalog # 220-04-02, serial numbers 0886395 - 0886424 Iris Sample Processing StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Serial numbers: B1562 to B1738 Dako Colorado Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1 Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial numbers SA060410 Access Point Medical Canes, various models Medical Device Control Office MHRA 2006/007/005/601/166 MHRA 2006/011/024/601/421 Field Safety Corrective Action Field Safety Corrective Action Health Canada 32733 Type II Recall 2006/11/27 Elekta Ltd. 2892 4320 MHRA 2006/011/009/291/005 Field Safety Corrective Action 2006/11/28 N/A N/A FDA Z-0117-2007 Class II Recall 2006/11/29 Abbott Laboratories Ltd. 2806 4201 FDA Z-0191-2007 & Z-0192-2007 Class II Recall 2006/11/29 N/A N/A FDA Z-0196-2007 Class II Recall 2006/11/29 N/A N/A FDA Z-0198-2007 Class II Recall 2006/11/29 N/A N/A FDA Z-0199-2007 Class II Recall 2006/11/29 N/A N/A FDA Z-0201-2007 Class II Recall 2006/11/29 Hong Kong Oxygen & Acetylene Co. Ltd. 2666 1942 FDA Z-0202-2007 to Z-0205-2007 Class II Recall 2006/11/29 N/A N/A 106 The local agent informed that no affected units had been distributed in Hong Kong. Click on the Press Release by AMO Asia for details: AMO's Press Release The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR SA060411 Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess Catheter), Model TA-XP-001, all codes Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, Catalog no. 05-5998-038-02, Lot 60472442 Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, Catalog no. 00-4309-018-10, Lots: 60457716 and 60492624 Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV product code 5000230 Model ID, product code 5000330 Vygon Paediatric 96Hr IV Filter 0.22M + extension line 0807.205 FDA Z-0208-2007 Class II Recall 2006/11/29 Medtronic International, Ltd. 2919 1362 2992 0968 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-0209-2007 Class II Recall 2006/11/29 Zimmer PTE Ltd. (Hong Kong branch) FDA Z-0210-2007 Class II Recall 2006/11/29 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-0220-2007 Class II Recall 2006/11/29 Konica Minolta Business Solutions (HK) Ltd. 2565 8181 The local agent informed that no affected units had been distributed in Hong Kong. MHRA 2006/011/017/401/001 2006/11/29 N/A N/A SA060416 Smiths Medical International Monitor Patient-BCI Autocorr 3404 MHRA 2006/011/022/291/010 2006/11/29 Smiths Medical (S.E. Asia) Ltd. 2317 0988 SA060417 Pegasus Ltd. Altas and Paragon Bed Frames MHRA 2006/011/003/261/001 SA060418 Bayer HealthCare ADVIA Centaur CP Immunoassay System MHRA 2006/011/027/601/428 SA060412 SA060413 SA060414 SA060415 Medical Device Control Office Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 107 2006/11/29 N/A N/A 2006/11/29 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 The manufacturer informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong. Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - October 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information* Computerized Medical Systems Software Releases 2.1.0 SA060247 Health Canada 32273 Type II Recall 2006/10/02 N/A 4.3.0, all lot numbers Hill-Rom Patient Pendants, model or catalog # P3207A01 & SA060248 Health Canada 32294 Type II Recall 2006/10/02 Solar Medical Ltd. P3207A02 Radiometer Medical APS CAL 2 Solution, model or catalog # SA060249 Health Canada 32100 Type II Recall 2006/10/02 N/A S1730, lot or serial number QR-02 Baxter Healthcare Colleague 3 Volumetric Infusion Pump, SA060250 models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 & Health Canada 32333 Type II Recall 2006/10/02 Baxter Healthcare Ltd. DNM8153R Ondine Biopharma Periowave Disinfection System Footswitch, Health Canada 32178 Type II Recall 2006/10/02 N/A SA060251 model or catalog # PW1002 and PW1100, lot or serial number PW-D06-00001 to PW-D06-00400 Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K. Medical Device Market SA060252 N/A 2006/10/03 Boston Scientific H. K. Ltd. specific lots Ltd. Withdrawal Huntleigh birthing beds, Models 35000 and 170000; Hoskins SA060253 MHRA MDA/2006/057 Action 2006/10/03 N/A Birthcare, Models L10 and L05 Baxter Healthcare, Administration Set-Continu Flo Solution Sets Field Safety Corrective SA060254 MHRA 2006/009/020/291/016 2006/10/03 Baxter Healthcare Ltd. with Check Valve Action Field Safety Corrective SA060255 B. Braun Arterial / Venous Blood Line, 7210697 MHRA 2006/009/026/291/011 2006/10/03 B. Braun Medical (Hong Kong) Ltd. Action Terumo Khuri Myocardial PH Monitoring System, Catalog SA060256 FDA Z-1517-06 Class II Recall 2006/10/04 Terumo China (H.K.) Ltd. number 7205 Kerr RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637 BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder SA060258 Number 305945 and 305950 Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-100SA060259 1000000 International Medsurg Connection Allegiance Esmark SA060260 Bandages, catalog numbers 24593-043A, 24593-044A, 24593063A and 24593-064A SA060257 Agent Contact Telephone No. N/A 2425 0926 N/A 2807 8556 2960 7117 N/A 2807 8556 2277 6125 2866 0811 Z-1524-06 Class II Recall 2006/10/04 N/A N/A FDA Z-1525-06 Class II Recall 2006/10/04 Becton Dickinson Asia Ltd. 2575 8668 FDA Z-1526-06 Class II Recall 2006/10/04 N/A N/A FDA Z-1527-06 to Z-1530-06 Class II Recall 2006/10/04 N/A N/A SA060261 INO Therapeutics INOvent System O Ring Failures MHRA 2006/004/003/401/004 2006/10/04 Hong Kong Oxygen & Acetylene Co. Ltd. 2666 1942 SA060262 Codan Great Britain Pump volumetric Argus 708 MHRA 2006/007/012/291/010 2006/10/04 N/A N/A Abbott Laboratories Ltd. 2806 4841 SA060263 SA060264 SA060265 SA060266 SA060267 Abbott Laboratories AsSYM Myoglobin Reagent Kit List Number 7K48-20 Varian 4D Integrated Treatment Console treatment control station for radiation therapy linear accelerators GE Healthcare Technologies (Prev Datex Ohmeda) Monitor Patient - N-AC BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human HLA-DR, DP, DQ Monoclonal Antibody, Clone TU39, Cat. No. 555556 Prorhtym Cardiac ablation system - 25mm & 30mm HIFU ablation catherter MHRA 2006/009/029/601/319 Varian Medical Systems Pacific Inc. 2006-022 MHRA 2006/009/027/601/315 Becton Dickinson Asia Ltd. N/A MHRA 2006/007/013/081/002 SA060268 Abbott Laboratories CELL-DYN 22 Calibrators-99120-01 MHRA 2006/010/002/901/325 SA060269 Cory Bros Ltd, Tubing suction - Ref: CST/50/6 MHRA 2006/008/015/401/002 Customer Notification Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2006/10/04 2006/10/06 2006/10/06 2006/10/09 Varian Medical Systems Pacific Inc. GE Medical Systems Hong Kong Ltd. Becton Dickinson Asia Ltd. 2783 1838 2575 8668 2006/10/10 N/A N/A 2006/10/11 Abbott Laboratories Ltd. 2806 4841 2006/10/11 N/A N/A FDA Z-0704-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1301-06 to Z-1303-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1514-06 Class II Recall 2006/10/11 Smith & Nephew Healthcare Ltd. 2645 8703 SA060273 GE Precision RX/I System, all units FDA Z-1485-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd. 2783 1838 Pointe Scientific Alcohol reagent sets and control standards, SA060274 various models FDA Z-1543-06 to Z-1549-06 Class II Recall 2006/10/11 Evergreen Health Care Ltd. 2893 0694 Medical Device Control Office 108 The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2724 2836 GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system GE OEC Medical Systems 9900 Elite Digital Mobile C-arm XSA060271 ray system, 9800 Fluoro C-arm X-ray system and RUS Tool Version Software Smith & Nephew Hip Positioning System with various System SA060272 Components SA060270 1 affected unit was distributed in Hong Kong. N/A FDA Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Correction Field Safety Corrective Action Remarks The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR GE OEC Medical Systems 4 inch Anterior Cervical Post, Part SA060275 Number: 1006385 or 1006385-NAV, an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems Thoratec brand TLC-11 Portable Ventricular Assist Device SA060276 (VAD) Driver Stryker Navigation Systems with Dell laptop computer model SA060277 D800 Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch, SA060278 Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II Oversized Nonporous Fin-Stem Tibial Punch GE Medical Systems Hong Kong Ltd. Class II Recall 2006/10/11 FDA Z-0004-07 Class II Recall 2006/10/11 N/A N/A FDA Z-0005-07 to Z-0008-07 Class II Recall 2006/10/11 Stryker Hong Kong 2518 6915 The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-0009-07 to Z-0011-07 Class II Recall 2006/10/11 Smith & Nephew Healthcare Ltd. 2645 8703 The local agent informed that no affected units had been distributed in Hong Kong. SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets MHRA 2006/004/027/601/094 Field Safety Corrective Action 2006/10/12 N/A N/A SA060166 Jenx Ltd. Seating support systems for children MHRA MDA/2006/059 Immediate Action 2006/10/12 N/A N/A SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281 N/A Product Field Action Notification 2006/10/13 Becton Dickinson Asia Ltd. 2575 8668 SA060237 N/A Important Information 2006/10/13 St. Jude Medical (Hong Kong) Ltd. 2996 7650 The local agent has already informed all the concerned hospitals and doctors. P06-167 FDA News 2006/10/13 Johnson & Johnson Medical Hong Kong 2735 8262 Updated on 2006/10/23. Please see SA060241 for details. 2006/010/003/081/006 Field Safety Corrective Action 2006/10/16 Beijing Since Medical Scientific Co. Ltd. 9262 1527 32353 Type II Recall 2006/10/16 Becton Dickinson Asia Ltd. 2575 8668 32288 Type II Recall 2006/10/16 N/A N/A 32120 Type II Recall 2006/10/16 Gambro China Ltd. 2576 2688 1 affected unit was distributed in Hong Kong. 32374 Type II Recall 2006/10/16 BioMerieux China Limited 2356 7033 The local agent informed that no affected units had been distributed in Hong Kong. SA060281 SA060282 SA060283 Becton Dickinson Asia Ltd. St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650 programmers used with certain St. Jude Identity pacemakers St. Jude Medical, Inc. (Identity SR Model 5172, Identity DR Model 5370 and Identity XL DR Model 5376) LifeScan OneTouch Basic/Profile (lot # 272894A, 2619932, 2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose FDA Test Strips AGA Medical Corporation Delivery System Amplatzer TorqVue MHRA Delivery and Exchange Systems BD Procount Progenitor Cell Enumeration, Part No. 340498, Lot Health Canada No. 45602 Walter Lorenz Surgical Lactosorb Suspension Screw, model or Health Canada catalog # 915-2335, lot or serial # 753200 SA060284 Teraklin AG Mars Treatment Kit SA060285 SA060286 SA060287 SA060288 SA060289 SA060290 SA060291 Health Canada Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot or Health Canada serial # 50417 Michigan Instruments Thumper Mechanical CPR Device, model Health Canada or catalog # 1007 Randox Laboratories Fructosamine Control Level 1, lot or serial Health Canada # 239FR Boston Scientific Interlock Detachable Coils For Occlusion, lot Boston Scientific H. K. number 6628239 Ltd. Boston Scientific Renegade 18 Microcatheter, lot number Boston Scientific H. K. 7513978 Ltd. Boston Scientific Stainless Steel Greenfield Vena Cava Filter, Boston Scientific H. K. lot number 7826572 Ltd. Advanced Bionics Linear Family Leads (product numbers SCAdvanced Bionics 2108, SC-2138, SC-2148 series) 2783 1838 The local agent informed that no affected units had been distributed in Hong Kong. Z-0001-07 SA060236 FDA 32375 Type II Recall 2006/10/16 Beijing Ji Yuan Electronic Co. (86)10-6202-3856 32310 Type II Recall 2006/10/16 N/A N/A 2006/10/17 Boston Scientific H. K. Ltd. 2960 7117 2006/10/17 Boston Scientific H. K. Ltd. 2960 7117 2006/10/17 Boston Scientific H. K. Ltd. 2960 7117 2006/10/17 Boston Scientific H. K. Ltd. 2960 7117 N/A N/A N/A Urgent Medical Device Recall Urgent Medical Device Recall Urgent Medical Device Recall The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 3 affected units were distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. N/A Important Notification MHRA 2006/010/013/601/347 Field Safety Corrective Action 2006/10/17 Elekta Ltd. 2891 2208 FDA Z-0015-2007 Class II Recall 2006/10/18 N/A N/A FDA Z-0027-2007 Class II Recall 2006/10/18 3M Hong Kong Ltd. 2806 6314 FDA Z-0029-2007 Class II Recall 2006/10/18 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-0030-2007 Class II Recall 2006/10/18 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. SA060297 AGFA CR DX-S Image Intensified Fluoroscopic X-ray system FDA Z-0031-2007 Class II Recall 2006/10/18 Agfa Hong Kong Ltd. 2555 9421 Haemonetics SmartSuction Harmony Powered Suction Device, SA060298 Model number: HAR-E-115-US FDA Z-0035-2007 Class II Recall 2006/10/18 Haemonetics (Hong Kong) Limited 2868 9218 2006/10/19 Roche Diagnostics (Hong Kong) Limited 2485 7555 SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0 Thoratec brand Sealed Arterial Cannula for use with the Thoratec Ventricular Assist Device System 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 SA060294 Sterilization Systems, Lot numbers 2006-12 AA through 200806 AB Medical Systems MRP-7000 and AIRIS Magnetic Hitachi SA060295 Resonance Imaging Systems, Software Versions: V7.0A to V7 0J Arrow Double-Lumen Balloon Wedge Pressure Catheter, for SA060296 sampling blood for oxygen levels and measuring pressures in the right heart SA060293 SA060299 Roche Diagnostics CoaguChek PT test strips Medical Device Control Office FDA N/A Press Release 109 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR SA060239 Sunrise Medical Jay J2, Wheelchair back SA060240 Medtronic SynchroMed EL Programmable Infusion Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18 SA060300 Lenox-Maclaren Bone Fragmenter, Catalog # 9150111, all lots SA060301 SA060241 SA060302 SA060303 SA060304 SA060242 SA060305 SA060306 SA060307 SA060308 SA060309 SA060310 SA060311 Olympus Life and Material Science Europa GmbH - CRP Latex C-Reactive Protein (OSR6199) LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips GF Health Products ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed BD Vacutainer Push Button Blood Collection Set with Preattached Holder, Catalog numbers 367352 and 368656 Medline Industries Strider Maxi 3 and Maxi 4 Scooters, red and blue models, all serial numbers Eagle Parts and Products Models 624EZ and 624Mini Power Wheel Chairs with internally threaded wheel mount motors, Serial numbers 624EZ0010 through 624EZ0513 GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210 GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210 Bioplate Resorbable Bone Fixation Tack, Catalog Number 890120, Item Number SG#-45, Lot number S2964090 Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Lot: 22-0109D Eatonform Doc-U-Dose Prescription Management System, Item #8-PKIT, lots 312733, 312734, 313767 and 313768 Draeger Fabius GS Anesthesia Machine, Catalog number 8604699 Del Medical DynaRad Phantom Portable X-Ray System, Phantom model (PH-150-CM & PH-150-G) Medtronic Sofamor Danek Implant Hollow Reamer, 14 mm, REF 8951405, Lot Numbers CN04J012 and CN 06A003 AGA Medical AMPLATZER PFO Occluder, Order No. 9-PFO018 and 9-PFO-025 GE ApexPro CH Telemetry System, Software version 3.8 and earlier MHRA MDA/2006/060 FDA Z-0022-0007 Medtronic International, Ltd. N/A MHRA 2006/007/027/291/001 FDA P06-174 Action 2006/10/19 N/A N/A Class I Recall 2006/10/20 Medtronic International, Ltd. 2919 1362 2006/10/20 Medtronic International, Ltd. 2919 1362 2006/10/23 Olympus Hong Kong Ltd 2376 1805 2006/10/23 Johnson & Johnson Medical Hong Kong 2735 8262 Voluntary Field Corrective Action Field Safety Corrective Action FDA News FDA Z-0026-2007 Class II Recall 2006/10/25 N/A N/A FDA Z-0034-2007 Class II Recall 2006/10/25 Becton Dickinson Asia Ltd. 2575 8668 FDA Z-0036-2007 & Z-00372007 Class II Recall 2006/10/25 N/A N/A FDA Z-0039-2007 & Z-00402007 Class II Recall 2006/10/25 N/A N/A FDA Z-0041-2007 Class II Recall 2006/10/25 FDA Z-0042-2007 Class II Recall 2006/10/25 FDA Z-0043-2007 Class II Recall 2006/10/25 GE Medical Systems Hong Kong Ltd. GE Medical Systems Hong Kong Ltd. Johnson & Johnson Medical Hong Kong 2783 1838 2783 1838 2738 6080 FDA Z-0044-2007 Class II Recall 2006/10/25 N/A N/A FDA Z-0045-2007 Class II Recall 2006/10/25 N/A N/A FDA Z-0048-2007 Class II Recall 2006/10/25 Draeger Medical Hong Kong Ltd. 2877 3077 FDA Z-0049-2007 Class II Recall 2006/10/25 N/A N/A FDA Z-0050-2007 Class II Recall 2006/10/25 Medtronic International, Ltd. 2919 1362 FDA Z-0052-2007 & Z-00532007 Class II Recall 2006/10/25 FDA Z-0055-2007 Class II Recall 2006/10/25 SA060315 Omega truCATH catheters (TCH-10) MHRA 2006/010/004/401/021 SA060316 Southern Scientific Autotilt ultrasound couches MHRA 2006/070/019/601/356 MHRA 2006/010/020/081/015 Respironics, Inc. N/A Health Canada SA060312 SA060313 SA060314 SA060317 SA060327 SA060243 SA060244 SA060318 SA060319 SA060320 SA060321 Siemens MAGNETOM Trio and MAGNETOM Trio a Tim magnetic resonance imaging systems Respironics REMstar Heated humidifier, model nos. 1007861, R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive) BHM Medical Kwiktrak Fix Gate, Model or Catalog # 700.11500 and 700.11505 Sunrise Medical Canada 5in Wheels Kits and Guardian Walkers Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr, Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed Cuffed Oral Endo.5mm, Sheridan Preformed Uncuffed Oral Endo. and Sheridan Tracheal Tube Exchanger AMD-Ritmed Abdominal Pads, Model or Catalog # A-7059, Lot or Serial # 2095 GE Centricity Triwin Laboratory Information System Microbiology Module, Version 7.4 Smith & Nephew Legion Offset Coupler Trials, Model or Catalog # 71434301, 71434302, 71434304 and 71434306 Medical Device Control Office Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Beijing Since Medical Scientific Co. Ltd. GE Medical Systems Hong Kong Ltd. 9262 1527 2783 1838 Supersedes the MDA/2006/056 (Ref: SA060163). The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Update to SA060236. For enquiry, please contact the local agent. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. According to FDA, distribution of affected units was limited to the United States only. Pending the manufacturer's confirmation. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 2006/10/25 N/A N/A 2006/10/25 N/A N/A 2006/10/25 Siemens Ltd. 2870 7533 The local agent informed that no affected units had been distributed in Hong Kong. Urgent Medical Device Recall 2006/10/25 Celki Medical Company 2268 9229 With affected units in Hong Kong. 32430 Type I Recall 2006/10/30 N/A N/A Health Canada 32469 Type II Recall 2006/10/30 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. Health Canada 32449 Type II Recall 2006/10/30 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. Health Canada 32484 Type II Recall 2006/10/30 N/A N/A Health Canada 32311 Type II Recall 2006/10/30 GE Medical Systems Hong Kong Ltd. 2783 1838 Health Canada 32286 Type II Recall 2006/10/30 Smith & Nephew Healthcare Ltd. 2645 8703 110 The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR SA060322 Micrus Endovascular Guidewire Insertion Device, Lot or Serial # F22741, F22743 and F22744 Health Canada 32512 Type II Recall 2006/10/30 N/A N/A SA060245 LifeScan OneTouch SureStep Test Strips, Lot or serial # 2631383 Health Canada 32428 Type II Recall 2006/10/30 Johnson & Johnson Medical Hong Kong 2735 8262 2006/10/31 N/A N/A 2006/10/31 N/A N/A 2006/10/31 N/A N/A 2006/10/31 Beckman Coulter Hong Kong Ltd. 2240 6260 N/A N/A N/A N/A N/A N/A Alcon Hong Kong Ltd. 2161 0888 ConMed Detacha Tip Multi-Use Laparoscopic Instruments and SA060323 Disposable Hand Held Graspers and Dissectors MHRA 2006/010/025/081/009 SA060324 Galls Dyna Med patient transfer sheets MHRA 2005/001/010/401/003 SA060325 Biomet modular femoral heads MHRA 2006/010/024/181/005 MHRA 2006/010/026/111/002 SA060326 SA060246a SA060246b SA060246c SA060246d Beckman Coulter FC 500 MPL flow cytometry systems with MXP software versions 2.0 & 2.1 北京自然美光学有限公司亮洁倍润免揉搓去蛋白护理液、生产日期/批号06030015、规格360毫升上海海昌隐形眼镜光学有限公司海昌隐形眼镜多功能护理液、生产日期/批号20051027、规格500毫升广州保视宁光学产品有限公司保视宁去蛋白软性接触镜护理液、生产日期/批号2005/09/18、规格360毫升 Alcon Opti-Free Express Contact Lens Care Solution (爱尔康杀菌全护理液), lot number #63188F and manufacturing date Medical Device Control Office Beijing Health Inspection Website N/A Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Public Annoucement 111 2006/10/31 The manufacturer informed that no affected units had been distributed in Hong Kong. Extension of the recall case # SA060238. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The State Food and Drug Administration (SFDA) of the PRC informed that, among the four brands, only the Alcon brand is sold in Hong Kong. Alcon Hong Kong Ltd. informed that the affected lot of its product was not distributed in Hong Kong. Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - September 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information* Varian Medical Systems Pacific Gantry Direct Drive systems in Varian High Energy Clinac linear Varian Medical Urgent Medical Device SA060167 N/A 2006/09/01 Inc. accelerators Systems Pacific Inc. Correction Field Safety Corrective Zimmer PTE Ltd. (Hong Kong SA060168 Zimmer-M/DN, Trilogy, HGP II and Herbert Bone Screws MHRA 2006/007/013/081/005 2006/09/01 Action branch) Codman EDS III Drainage System, model or catalog # 82-1731, Johnson & Johnson Medical Hong SA060169 Health Canada 32097 Type II Recall 2006/09/04 lot or serial # CGHBGC and CGHBGD Kong Smith & Nephew Hewson Suture Retrievers Item 7111-1579, lot SA060170 Health Canada 32117 Type II Recall 2006/09/04 Smith & Nephew Healthcare Ltd. or serial # 05HSM0014 Mentor Clear Advantage With Aloe MECs, model or catalog # SA060171 Health Canada 32095 Type II Recall 2006/09/04 N/A 26-06100, 26-06200, 26-06300, 26-06400 & 26-06500 Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60 SA060172 Health Canada 31891 Type II Recall 2006/09/04 BioMerieux China Limited System and Vitek 2 System SA060173 Kueschall Airlite Manual Wheelchair, K Series 2005 SA060174 Boston Scientific PT2 Guide Wire SA060175 Baxter Healthcare Cryote Freezing Container SA060176 SA060177 SA060178 SA060179 SA060180 SA060181 Dideco Electa and Compact Advanced Autotransfusion Wash Sets Dade Behring Limited Dimension clinical chemistry system Tacrolimus (TACR) Flex reagent cartridge (DF107) Lots: FM6334, FD6344 and FA6351 Radiometer America Transcutaneous Monitor for pO2 and pCO2, Model # TCM4 BioGenex brand Hepatitis B Virus Core Antigen Antibody and Surface Antigen Antibody Diagnostica Stago Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay Radiometer America safePICO Samplers, self-filling arterial blood samplers SA060182 Delphi IVantage Volumetric Ambulatory Infusion Pump/System BD Unopette System Tests for Erythrocyte Fragility Test Kit, catalog # 365830 Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry SA060184 Systems, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests Pointe Scientific AutoHDL Cholesterol Reagent Sets, various SA060185 models Bayer Healthcare RapidLab 1200 Systems, models 1245 and SA060186 1265 - blood gases, electrolyte and blood pH test systems SA060183 Health Canada 32191 Boston Scientific H. K. Ltd. N/A MHRA 2006/008/031/081/004 MHRA 2006/008/029/291/003 2356 7033 2006/09/04 Direct Health Ltd. 2528 1109 2006/09/05 Boston Scientific H. K. Ltd. 2960 7117 2006/09/05 Baxter Healthcare Ltd. 2807 8556 2006/09/05 N/A N/A 2006/09/06 Dade Behring Hong Kong Ltd 2803 0118 Class II Recall 2006/09/06 N/A N/A FDA Z-1438-06 & Z-1439-06 Class II Recall 2006/09/06 Science International Corporation 2543 7442 FDA Z-1441-06 Class II Recall 2006/09/06 N/A N/A FDA Z-1443-06 Class II Recall 2006/09/06 N/A N/A FDA Z-1445-06 Class II Recall 2006/09/06 N/A N/A FDA Z-1446-06 Class II Recall 2006/09/06 Becton Dickinson Asia Ltd. 2575 8668 FDA Z-1448-06 to Z-1450-06 Class II Recall 2006/09/06 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 FDA Z-1454-06 to Z-1459-06 Class II Recall 2006/09/06 Evergreen Health Care Ltd. 2893 0694 FDA Z-1464-06 & Z-1465-06 Class II Recall 2006/09/06 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 2006/006/014/601/150 2006/008/015/121/001 Codman CSF External Drainage System III, 82-1731(EDS III SA060189 without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5, CGGCT8, CGGCT9 MHRA 2006/008/021/081/006 Boston Scientific H. K. Ltd. N/A MHRA 2006/008/010/401/007 MHRA 2006/008/024/081/004 SA060193 Sorin Group S5 Heart Lung Machine MHRA 2006/008/003/401/007 SA060194 Intavent Orthofix Laryngeal mask airway MHRA 2006/009/004/291/003 Medical Device Control Office N/A Z-1437-06 MHRA Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010 system 2645 8703 FDA MHRA SA060192 2738 6080 2006/009/004/291/014 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 112 Remarks The local agent informed all the affected users. 2992 0968 MHRA SA060188 Siemens Medical Solutions Siregraph CF SA060191 Penlon Sigma Delta Sevoflurane Vaporizer Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action 2724 2836 Field Safety Corrective Action SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System Type II Recall Agent Contact Telephone No. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 3 affected units were distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 2006/09/06 N/A N/A 2006/09/06 Siemens Ltd. 2870 7533 2 affected units in Hong Kong. 2006/09/07 Johnson & Johnson Medical Hong Kong 2738 6080 The local agent informed that no affected units had been distributed in Hong Kong. 2006/09/08 Boston Scientific H. K. Ltd. 2960 7117 2006/09/08 N/A N/A 2006/09/08 Roche Diagnostics (Hong Kong) Limited 2485 7555 2006/09/08 N/A N/A 2006/09/08 N/A N/A The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR Respironics NICO model 7300 Cardiopulmonary Management Celki Medical System - serial numbers beginning with 138Company Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H. K. SA060196 lot/batch number 6040734 Ltd. Boston Scientific H. K. SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867 Ltd. Radiometer America D826 Accessory kit for single tcpO2 SA060198 Electrodes for use with the TCM400 Transcutaneous Monitor FDA (Cutaneous Oxygen Monitor) Part Number: 904-308 Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems SA060199 FDA Femoral Stem and Body, various sizes SA060195 N/A N/A N/A Important Medical Device Recall Notification Urgent Medical Device Recall Urgent Medical Device Recall 2006/09/09 Celki Medical Company 2268 9258 2006/09/12 Boston Scientific H. K. Ltd. 2960 7117 2006/09/12 Boston Scientific H. K. Ltd. 2960 7117 N/A N/A Z-1436-06 Class II Recall 2006/09/13 Z-1467-06 to Z-1480-06 Class II Recall 2006/09/13 MHRA 2006/007/017/291/008 Field Safety Corrective Action 2006/09/14 Health Canada 32208 Type I Recall 2006/09/18 Stryker Hong Kong Health Canada 32272 Type I Recall 2006/09/18 Hong Kong Oxygen & Acetylene Co. Ltd. 2666 1942 Health Canada 32198 Type II Recall 2006/09/18 Draeger Medical Hong Kong Ltd. 2877 3077 Health Canada 32241 Type II Recall 2006/09/18 Baxter Healthcare Ltd. 2807 8556 Health Canada 32257 Type II Recall 2006/09/18 N/A N/A SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000 Health Canada 32134 Type II Recall 2006/09/18 Agfa Hong Kong Ltd. 2873 9336 GE OEC Medical Systems OEC Mini 6800 C-ARM, various lot or serial numbers Health Canada 32268 Type II Recall 2006/09/18 MHRA MDA/2006/054 Immediate Action 2006/09/18 FDA Z-1461-06 to Z-1463-06 Class II Recall 2006/09/20 Becton Dickinson Asia Ltd. 2575 8668 FDA Z-1487-06 Class II Recall 2006/09/20 Philips Electronics Hong Kong Ltd. 2876 7525 FDA Z-1496-06 & Z-1497-06 Class II Recall 2006/09/20 N/A SA060200 AGA Medical Amplatzer VSD Occluder SA060159 SA060160 SA060201 SA060202 SA060203 SA060205 Stryker Biotech Calstrux, model or catalog # 400-05CN, 40010CN and 400-15CN Datex-Ohmeda Aisys Carestation, model or catalog # 10119000-000 Draeger Medical Infant Care Isolette C2000 Incubators, model or catalog # C2HS Baxter Healthcare Continu-Flo Sets With Check Valve, various models or catalog numbers AMG Medical IV Pole, model or catalog number 775-855P and 775-860 SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula, Vacutainer Luer Adapter and Direct Draw Adapters Philips Medical Systems IntelliVue MultiMeasurement Server SA060207 (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A Skytron General Purpose Surgical Table, Models 6600 and SA060208 6600B (battery model) SA060206 Zimmer PTE Ltd. (Hong Kong branch) Beijing Since Medical Scientific Co. Ltd. GE Medical Systems Hong Kong Ltd. Johnson & Johnson Medical Hong Kong SA060209 Greiner bio-one Vacuette Tube, Item # 454332, lot # B050609 FDA Z-1498-06 Class II Recall 2006/09/20 Mekim Ltd. SA060210 Xiros Plc Neoligaments 6mm and 8mm Staple Impactors FDA Z-1500-06 & Z-1501-06 Class II Recall 2006/09/20 N/A 2992 0968 9262 1527 2518 6915 2738 2818 MHRA 2006/009/019/181/008 2006/09/20 N/A FDA Z-1503-06 Class II Recall 2006/09/22 (1) Solar-Med Ltd; (2) Goodman Medical Supplies Ltd. Smith and Nephew Genesis II Non-porous fin Stem Tibial SA060212 Punches, Codes 711440480, 71440482, 71440484 and 71440486 MHRA 2006/009/015/131/001 Field Safety Corrective Action 2006/09/22 Smith & Nephew Healthcare Ltd. 2645 8703 SA060213 Huntleigh birthing beds, Models 35000 and 170000 MHRA 2005/007/018/291/018 2006/09/22 N/A N/A SA060214 Hoskins Lifecare birthing beds- Models L05 an dL10 MHRA 2005/007/018/291/018 2006/09/22 N/A N/A SA060215 Smith and Nephew TC100 2.7mm Cortical Bone Screws MHRA 2006/009/020/291/027 2006/09/22 Smith & Nephew Healthcare Ltd. 2645 8703 MHRA 2006/009/022/291/010 2006/09/25 Johnson & Johnson Medical Hong Kong 2738 2818 2006/09/26 Boston Scientific H. K. Ltd. 2960 7117 2006/09/26 N/A N/A 2783 1838 2575 8668 SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector GE Precision 500D Radiographic and Fluoroscopic Imaging SA060219 System, all serial numbers BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and SA060220 240953 Medical Device Control Office Boston Scientific H. K. Ltd. N/A MHRA 2006/009/011/601/207 FDA Z-1304-06 Class II Recall 2006/09/27 GE Medical Systems Hong Kong Ltd. FDA Z-1505-06 Class II Recall 2006/09/27 Becton Dickinson Asia Ltd. 113 The local agent informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 64 affected units in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been 2774 8339 distributed in Hong Kong. The manufacturer informed that no affected units had been N/A distributed in Hong Kong. The manufacturer informed that no affected units had been N/A distributed in Hong Kong. (1) 2425 0926; (2) 2332 15 affected units in Hong Kong. Rectification programme 4455 completed. SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700 Biosense Webster Europe RefStart Catheter with QwikPatch External Reference Patch Boston Scientific Flexima all purpose drainage catheters, lot SA060217 number 8955327 The local agent informed that no affected units had been distributed in Hong Kong. The local agent will inform all the future users about the concerned issue. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. N/A SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves SA060216 The manufacturer informed that no affected units had been distributed in Hong Kong. 2783 1838 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action 2 affected units in Hong Kong. Rectification programme has been completed. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong. Department of Health The Government of HKSAR SA060221 Conmed System 2500 and 5000 Electrosurgical Units FDA Z-1507-06 & Z-1508-06 Class II Recall 2006/09/27 N/A N/A Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual SA060222 wheelchairs FDA Z-1509-06 to Z-1511-06 Class II Recall 2006/09/27 Direct Health Ltd. 2528 1109 SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500 FDA Z-1513-06 Class II Recall 2006/09/27 Stryker Hong Kong 2518 6915 Z-1521-06 Class II Recall 2006/09/27 N/A N/A 2006/09/27 Beckman Coulter Hong Kong Ltd. 2240 6260 2006/09/27 GE Medical Systems Hong Kong Ltd. 2783 1838 2006/09/27 Smiths Medical (S.E. Asia) Ltd. 2317 0988 2006/09/28 Boston Scientific H. K. Ltd. 2960 7117 2006/09/28 Becton Dickinson Asia Ltd. 2575 8668 2006/09/28 Abbott Laboratories Ltd. 2806 4841 SA060224 SA060225 SA060226 SA060227 SA060228 SA060229 SA060230 SA060231 Kerr Optibond Solo Plus Self-Etch Adhesive System, Part FDA Number 31966 Beckman Coulter LH700 series Hematology Analyzers 2B3 2B4 MHRA and 2B5 Software GE Healthcare Technologies Gas absorbers Compact Absorber MHRA 427002000 Smiths Medical Chest Drain - Portex Chest Drainage System MHRA with Adjustable Straw - 2000ml Boston Scientific Vaxcel Implantable Chest Ports with PASV Boston Scientific H. K. Valve Technology, specific lots Ltd. BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot # Becton Dickinson 6152968 and BD Procount (IVD), lot # 340398 Asia Ltd. Abbott Laboratories FSH calibrator and AsSY Master calibrator MHRA batches Abbott Laboratories CELL-DYN Sapphire List Number 08H00MHRA 01 SA060163 Sunrise Medical Jay J2, Wheelchair back CryoCath Arctic Circler Curvilinear Cardiac Cryoablation SA060164 Catheters, catalog nos. 2AC20, 2AC22, 2AC24, 2AC26 and 2AC30 AMO COMPLETE Amino Moist Multi-Purpose Solution, 360mL SA060165 x 2, lot numbers ZB02542, ZB02563, ZB02567 and ZB02575 Coloplast Drainage bag - 5062 - Conveen Urine Bag, 1500ml, SA060232 90cm tube MHRA CryoCath Technologies, Inc. Advanced Medical Optics, Inc. 2006/009/022/291/004 2006/009/005/601/267 2006/009/025/291/001 N/A N/A 2006/009/027/601/314 2006/008/025/601/253 MDA/2006/056 N/A N/A MHRA 2006/009/019/181/006 SA060233 Micrus Endovascular Watusi Guide Wire System MHRA 2006/009/019/181/004 Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245, SA060234 LI146, LI163 MHRA 2006/009/004/291/006 SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J MHRA 2006/009/025/401/010 LifeScan Inc. N/A LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008) SA060238 and OneTouch SureStep (part #020-052, lot #2627353) Blood Glucose Test Strips Medical Device Control Office Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Medical Device Recall Worldwide Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed all the affected users. 2006/09/28 Abbott Laboratories Ltd. 2806 4841 Action 2006/09/28 N/A N/A Market Withdrawal 2006/09/28 Pacific Medical (HK) Ltd. 2343 8009 The local agent informed all the affected users. 2006/09/28 AMO Asia Limited 2401 5861 The local agent informed that no affected units had been distributed in Hong Kong. 2006/09/29 N/A N/A 2006/09/29 N/A N/A 2006/09/29 N/A N/A 2006/09/29 N/A N/A 2006/09/29 Johnson & Johnson Medical Hong Kong 2735 8262 Voluntary Limited Market Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Press Release 114 The local agent informed all the affected users. Superseded by MDA/2006/060. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - August 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information* Field Safety Corrective SA060070 Biotronik - Stratos LV-T Pacemaker MHRA 2006/007/027/291/016 2006/08/01 N/A Action Dade Behring N Rheumatology Standard SL for RF, N/T Field Safety Corrective SA060071 MHRA 2006/006/026/131/002 2006/08/01 Dade Behring Hong Kong Ltd Rheumatology Control SL/1 and SL/2 for RF on BN System Action Becton Dickinson Vacutainer Direct Draw adaptor product code SA060072 MHRA MDA/2006/043 Action 2006/08/02 Becton Dickinson Asia Ltd. 364896 and Vacutainer Luer adaptor product code 367300 SA060073 AFOS Ltd. Endoscope storage facility (ESF) SA060074 SA060075 SCC Soft Computer SoftPath ASXII Software Releases 2.3.0 and 4.3.7 SCC Soft Computer SoftPath ASCII Software, Releases 1.2, 2.1, and 2.3 Brainlab ExacTrac Robotics for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System St. Francis Medical Technologies brand X STOP® Interspinous Process Decompression (IPD) System Radiometer America Waste tubing, Model # 842-326 (pump tube for waste) and Model # 842-327 (pump tube for solution) Agent Contact Telephone No. N/A 2803 0118 2575 8668 MHRA MDA/2006/044 Action 2006/08/02 N/A N/A FDA Z-1243-06 Class II Recall 2006/08/02 N/A N/A FDA Z-1252-06 Class II Recall 2006/08/02 N/A N/A FDA Z-1255-06 Class II Recall 2006/08/02 Brainlab Ltd. (Hong Kong) 2417 1881 FDA Z-1258-06 Class II Recall 2006/08/02 N/A N/A FDA Z-1260-06 Class II Recall 2006/08/02 N/A N/A SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120 FDA Z-1261-06 Class II Recall 2006/08/02 N/A N/A Radiometer America Radiance Data Management System SA060080 Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System FDA Z-1262-06 Class II Recall 2006/08/02 N/A N/A Z-1263-06 to Z-1265-06 Class II Recall 2006/08/02 N/A N/A Z-1266-06 & Z-1267-06 Class II Recall 2006/08/02 Terumo China (H.K.) Ltd. 2866 0811 SA060076 SA060077 SA060078 SA060081 Microcuff Pediatric and Adult Endotracheal Tubes, various sizes FDA Terumo Advanced Perfusion System 4 inch diameter Roller SA060082 Pump (model 801040) and 1 Large Roller Pump (model FDA 801041) Varian Medical Systems Gamma Win software, part number SA060083 FDA GM11019110, versions up to and including 1.62 Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, SA060084 FDA various sizes LifeCell Repliform Tissue Regeneration Matrix, catalog Boston Scientific H. K. SA060085 numbers 820241, 820245 and 820246 Ltd. Z-1268-06 to Z-1270-06 Class II Recall 2006/08/02 Z-1271-06 to Z-1285-06 Class II Recall 2006/08/02 N/A SA060086 Corin Ltd. Standard Neck Modular Head 28mm MHRA 2006/007/031/601/190 the Binding Site, Freelite human kappa free kit & human SA060087 lambda free kit assays used on Hitachi & BNII instruments MHRA 2006/007/003/291/017 SA060088 Abbott Laboratories Cystic Fibrosis V3 Genotyping Assay MHRA 2006/008/001/601/092 SA060089 Technovent Optical Conformer Impression Conformer SA060090 SA060091 SA060092 SA060093 SA060094 SA060065 SA060066 Integra Neurosciences Ultrasonic surgical Aspirator System, model or catalog # 1529161 and 1529165 Tomotherapy Incorporated HI-ART System, Lot or Serial # 10009, 10037 and 10014 Medrad Neurovascular Array Coils, model or catalog # M64NVA GE Healthcare Innova 2100IQ, lot or serial # 469545BU6 and 479238BU8 Sunrise Medical CCG Joerns Ultracare Model 770 AC Powered beds, model or catalog # U770, U770-GNDAL and U770AL BHM Medical Reacher for Transportable Ceiling Lift, Model or Catalog # 700.08310 and 700.08320 Nellcor Puritan Bennett Satin-Slip Intubating Stylet, Model or Catalog # 85863, Lots beginning with 05 and 06 2724 2836 2992 0968 2006/08/03 Boston Scientific H. K. Ltd. 2960 7117 2006/08/03 N/A N/A 2006/08/03 Bio-Gene Technology Ltd. 2646 6101 2006/08/03 Abbott Laboratories Ltd. 2806 4841 MHRA 2006/007/031/081/009 2006/08/04 N/A N/A Health Canada 30936 Type II Recall 2006/08/07 N/A N/A Health Canada 31533 Type II Recall 2006/08/07 N/A N/A Health Canada 31863 Type II Recall 2006/08/07 Ultronics Enterprise Ltd. 2764 5208 2783 1838 N/A The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Health Canada 31920 Type II Recall 2006/08/07 GE Medical Systems Hong Kong Ltd. Health Canada 31981 Type II Recall 2006/08/07 N/A Health Canada 31344 Type I Recall 2006/08/07 N/A N/A Health Canada 31892 Type I Recall 2006/08/07 Tyco Healthcare (HKSAR) Limited 3157 7244 2006/08/07 Roche Diagnostics (Hong Kong) Limited 2485 7555 The manufacturer informed all the affected users. 2006/08/07 Smiths Medical (S.E. Asia) Ltd. 2317 0988 The local agent informed that no affected units had been distributed in Hong Kong. SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent MHRA 2006/007/013/291/005 SA060096 Smiths Medical International-Custom Epidural Pack MHRA 2006/007/031/081/001 Medical Device Control Office Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Varian Medical Systems Pacific Inc. Zimmer PTE Ltd. (Hong Kong branch) Remarks The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. Field Safety Corrective Action Field Safety Corrective Action 115 69 affected units in Hong Kong. Department of Health The Government of HKSAR Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action SA060097 Smiths Medical Catheter, central venous MHRA 2006/007/027/291/010 Baxter Healthcare Blood cell separator Amicus Apheresis Kit SA060098 (Lot A06C21046, A06D10088, A06D10237, A06D25060) MHRA 2006/007/013/291/004 03a SA060099 Medtronic Midas Rex Classic GS and Legend dissecting tools MHRA 2006/008/002/291/003 SA060100 Sedana Medical AnaConDa Anaesthetic conserving device MHRA MDA/2006/045 Action FDA Z-1305-06 FDA Z-1315-06 SA060101 SA060102 SA060103 SA060104 SA060105 SA060106 Kensey Nash TriActiv ProGuard Embolic Protection System, part number 61000-01 Applied Biotech Medplus ER Drug Screen Test, Model # 5800KAB Radiometer Medical Aps Capilliary blood sample tube caps contained in safe clinitube kits CryoCath Arctic Circler curvilinear cardiac cryoablation catheters, catalog no. 2AC30 and lot nos. 50103, 50312, 50327, 50418, 00035, 00169, 00486 Therakos Therakos UVARXTS small bowl procedural kit (Catalog No. XT125). Lot nos. U706, U707, U708, U709, U710, U711 U712 DeSoutter Medical, Sagittal Blade-Opposed Tooth SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code: SA060108 367516 Male Ch16 Lot 696770 SA060109 Respironics Esprit Ventilator Power Supply SA060110 SA060111 SA060112 SA060113 Gambro Renal Prismaflex Continuous Renal Relacement System, Model 6023014700 Boston Scientific vanSonnenberg Sump Catheter, lot/batch number 8606405 Richard Wolf Single Use Tem Tubing Sets, Type 4170.801 Batch 060232 Abbott brand FreeStyle and FreeStyle Flash Blood Glucose Meters SA060114 MediSurg Fugo Blade Incising Tip Assembly SA060115 SA060116 SA060117 SA060118 SA060119 Tekia TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614 intraocular lens ArthroCare OPUS Speedstitch Suture Cartridge with Magnumwire, Catalog number OM-6006 Radiometer America Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 and ABL-800 Series Radiometer America Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer's CLINITUBES kits, Model # 904-439 and 904-453 Pointe Scientific Liquid Glucose HEX(R1), HEX(R2), HEX and HEXO Reagents and Reagent Sets SA060120 Zimmer sterile bone screws, various models and sizes SA060121 Edwards Lifesciences Aquarius Heamofiltration machine SA060122 Medicina Infant Feeding Tubes SA060067 Roche Diagnostics Accu-chek Advantage for Accudata GTS, Accu-Soft & Accu-Chek Advantage Blood Glucose Meters SA060068 Gambro Prismaflex Continuous Renal Replacement System Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or Catalog # 32536, lot or serial # 032AY1 & 139AY1 Beckman Coulter FP1000 Cell Preparation System, model or SA060124 catalog # 624922 SA060123 Medical Device Control Office 2006/08/07 Smiths Medical (S.E. Asia) Ltd. 2317 0988 2006/08/07 Baxter Healthcare Ltd. 2807 8556 2006/08/09 Medtronic International, Ltd. 2919 1362 2006/08/09 N/A N/A Class II Recall 2006/08/09 N/A N/A Class II Recall 2006/08/09 N/A N/A 2006/08/09 N/A N/A 2006/08/10 Pacific Medical (HK) Co. Ltd. 2755 6948 2006/08/10 N/A N/A 2006/08/10 N/A N/A 2006/08/11 N/A N/A 2006/007/010/291/001 Field Safety Corrective Action CryoCath Technologies Ltd. N/A Field Safety Corrective Action MHRA 2006/008/002/601/194 MHRA 2006/008/004/081/002 MHRA 2006/003/001/261/001 MHRA MHRA 2006/007/012/291/005 Celki Medical Company N/A MHRA 2006/007/031/081/014 Boston Scientific H. K. Ltd. N/A Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Urgent Field Action Notification Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action 2006/08/11 N/A N/A 2006/08/14 Celki Medical Company 2268 9228 2006/08/14 Gambro China Ltd. 2576 2688 2006/08/16 Boston Scientific H. K. Ltd. 2960 7117 MHRA 2006/008/015/081/011 2006/08/16 N/A N/A FDA Z-1306-06 & Z-1307-06 Class II Recall 2006/08/16 Abbott Laboratories Ltd. 2806 4210 FDA Z-1224-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1311-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1312-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1317-06 & Z-1318-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1321-06 & Z-1322-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1326-06 to Z-1333-06 Class II Recall 2006/08/16 N/A N/A FDA Z-1335-06 to Z-1351-06 Class II Recall 2006/08/16 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968 2006/08/17 N/A N/A MHRA 2005/005/006/401/010 MHRA 2006/007/010/291/007 Health Canada 31495 Field Safety Corrective Action Field Safety Corrective Action Type I Recall 2006/08/18 N/A N/A 2006/08/21 Roche Diagnostics (Hong Kong) Limited 2485 7510 Health Canada 31616 Type I Recall 2006/08/21 Gambro China Ltd. 2576 2688 Health Canada 32029 Type I Recall 2006/08/21 Bio-Rad Pacific Ltd. 2789 3300 Health Canada 31805 Type II Recall 2006/08/21 Beckman Coulter Hong Kong Ltd. 2240 6260 116 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed all the affected users. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 7 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. For further details, please see the website notice: http://www.mdco.gov.hk/english/recalls/recalls_20060828.htm l 2 affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR SA060125 Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery Systems, Hemodialysis Machine 1550, Machine 1550 Single Needle Hemodialysis and System 1000 Dialysate Delivery System, all serial numbers Health Canada 32017 Type II Recall 2006/08/21 Baxter Healthcare Ltd. 2807 8556 SA060126 Osmetech OPTI CCA Blood Gas & Electrolyte Analyz Health Canada 32028 Type II Recall 2006/08/21 N/A N/A SA060127 Smiths Medical Hotline L-10 Gas Vent Health Canada 32033 Type II Recall 2006/08/21 Smiths Medical (S.E. Asia) Ltd. 2317 0988 Health Canada 31890 Type II Recall 2006/08/21 Smith & Nephew Healthcare Ltd. 2645 8703 Health Canada 32037 Type II Recall 2006/08/21 N/A N/A Health Canada 32040 Type II Recall 2006/08/21 Siemens Ltd. 2870 7533 Health Canada 32043 Type II Recall 2006/08/21 Siemens Ltd. 2870 7533 Health Canada 32048 Type II Recall 2006/08/21 N/A N/A SA060128 SA060129 SA060130 SA060131 SA060132 Smith & Nephew Electroblade Resector 4.5, 4.5 Elite/FR and Trivex Resector Kit Edwards Lifesciences Vascushunt Silicone Balloon Shunt, model or catalog # T3103AS, lot or serial # 58220388 Siemens Arcadis Orbic and Arcadis Varic, model or catalog # 8081080 and 8080017 Siemens Lithoskop, model or catalog # 8355088, lot or serial # 1019 Nomos (North American Scientific) Corvus Planning System 6.0/6.1 Fujinon Mobile Endoscopy Cart, lot or serial # 125769, 125770, 125774, 125767 and 125772 The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 1 affected unit in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Health Canada 31389 Type II Recall 2006/08/21 Goodman Medical Supplies Ltd. 2332 4455 SA060134 Maquet Critical Care HL30 Perfusion System Health Canada 31875 Type II Recall 2006/08/21 Maquet Hong Kong Limited 2393 9511 SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers Health Canada 32059 Type II Recall 2006/08/21 Gambro China Ltd. 2576 2688 2 affected units in Hong Kong. Health Canada 32092 Type II Recall 2006/08/21 Siemens Ltd. 2870 7533 The local agent informed that no affected units had been distributed in Hong Kong. 2006/08/21 Beckman Coulter Hong Kong Ltd. 2240 6260 2006/08/21 Bayer Healthcare Ltd. (Hong Kong) 2814 4829 SA060133 Siemens Medical Solutions Oncology Care Systems ZXT SA060136 Treatment Table, model or catalog # 9820952 and 05844621 Beckman Coulter Unicel DxI 800 Access Immunoassay System SA060137 Wash Buffer SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser Cordis Neurovascular Pre-shaped Prowler and pre-shaped SA060139 PROWLER SELECT infusion catheters Roche Diagnostics Accu-chek Comfort Curve, Advantage, SA060140 Sensor Comfort and Inform Blood Glucose Meter Test Strips Orthopaedic implants manufactured by Proconcept SA France: CIFEC cervical cages; LIFEC lumbar cagesl ALIFEC lumbar SA060141 cages; SRE/SEO spinal screw systems; CANALETTO carpal tunnel protection implants SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30 SA060143 SA060144 SA060145 SA060146 SA060147 SA060148 SA060149 Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit, Catalog No. 1931601 Radiometer America Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 and ABL-800 Series Pointe Scientific Alkaline Phosphatase reagents, buffers and substrates, various models Varian Medical Systems GammaMed software programs for the GammaMed models 12i and 12it radionuclide applicator systems Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface Baxter Intermate and Infusor Large volume (LV) infusion pumps - all models Cardinal Health Alaris SE Pump (formerly Signature Edition Infusion Pump), all models SA060150 Chiltern Invadex ceiling track patient hoists with turntables SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide Delivery System, Model Number 1605-9000-000 Zimmer Trabecular Metal Reverse Shoulder System SA060153 Glenosphere and Base Plate BioCare Systems LumiWave 1X4 Infrared Therapy Device, SA060154 Catalog # LW1X4 SA060152 Medical Device Control Office MHRA 2006/008/016/081/005 MHRA 2006/008/015/121/002 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action MHRA 2006/008/016/081/012 FDA Z-1377-06 to Z-1384-06 Class II Recall 2006/08/22 MHRA MDA/2006/046 Immediate Action 2006/08/22 N/A N/A MHRA 2006/008/022/081/011 Field Safety Corrective Action 2006/08/23 Maquet Hong Kong Limited 2393 9511 FDA Z-1385-06 Class II Recall 2006/08/23 Roche Diagnostics (Hong Kong) Limited 2485 7555 FDA Z-1386-06 & Z-1387-06 Class II Recall 2006/08/23 N/A N/A FDA Z-1388-06 to Z-1397-06 Class II Recall 2006/08/23 Evergreen Health Care Ltd. 2893 0694 FDA Z-1398-06 & Z-1399-06 Class II Recall 2006/08/23 Varian Medical Systems Pacific Inc. 2724 2836 FDA Z-1401-06 Class II Recall 2006/08/23 Siemens Ltd. 2870 7533 MHRA MDA/2006/048 Action 2006/08/24 Baxter Healthcare Ltd. 2807 8556 FDA N/A Press Release 2006/08/28 The Vita Company Ltd. 2548 7483 MHRA MDA/2006/050 Action 2006/08/29 N/A N/A MHRA 2006/008/021/291/006 Field Safety Corrective Action 2006/08/30 B. Braun Medical (Hong Kong) Ltd. 2277 6125 FDA Z-1410-06 Class II Recall 2006/08/30 FDA Z-1416-06 to Z-1418-06 Class II Recall 2006/08/30 FDA Z-1419-06 Class II Recall 2006/08/30 117 2006/08/21 Johnson & Johnson Medical Hong Kong Roche Diagnostics (Hong Kong) Limited Hong Kong Oxygen & Acetylene Co. Ltd. Zimmer PTE Ltd. (Hong Kong branch) N/A 2738 2818 2485 7510 2666 1942 2992 0968 N/A The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR A & E Industries Guardian Walker and Guardian 5 inch Walker Wheel Kits, various models Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and SA060156 Optimin Hollow Fiber Sealed System Membrane Oxygenators/Reservoirs, various models MicroVision Medical MicroScan Lens Disposable Plastic Cap SA060157 used with MicroScan Video Microscope SA060155 SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors SA060158 Abbott Laboratories Xsystems CA 15-3 controls Medical Device Control Office FDA Z-1420-06 & Z-1421-06 Class II Recall 2006/08/30 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-1422-06 to Z-1429-06 Class II Recall 2006/08/30 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-1435-06 Class II Recall 2006/08/30 N/A N/A The manufacturer informed that no affected units had been distributed in Hong Kong. Medtronic International, Ltd. N/A 2006/08/31 Medtronic International, Ltd. 2919 1362 5 affected units in Hong Kong. Rectification completed. MHRA 2006/008/023/291/007 2006/08/31 Abbott Laboratories Ltd. 2806 4841 The manufacturer informed all the affected users. Urgent Medical Device Correction Field Safety Corrective Action 118 Department of Health The Government of HKSAR Monthly Summary of Medical Device Safety Alerts - July 2006 *Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada MDCO Ref. Description of Product Source of Reference No. by Source Alert Type by Source Date of Issue Local Agent (YYYY/MM/DD) No. Information* Boston Scientific Urgent Medical Device SA060001 Boston Scientific Expo and Impulse Angiographic Catheter N/A 2006/07/03 Boston Scientific Hong Kong Ltd. Hong Kong Ltd. Recall SA060002 Adept-Med brand Glassman Viscera Retainer FISH Suros Surgical ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09 Biomerieux OBSERVA R02 (version R02.00.17) computers SA060004 using PSC 6000 or HHP Barcode Scanners connected to BacT/ALERT 3D SA060003 SA060005 Leica M520 Surgical Microscope B. Braun 9F (O/S) Locking Tearway Introducers, non-sterile, Catalog number 614008 St. Jude Medical CPS Slitter, Valve Bypass Tool (VBT), Direct SA060007 SL, Aim and Implant Kit, various models Roche Calcium Reagent Kit for use on the Cobas MIRA SA060008 Chemistry System SA060006 SA060009 Welch Allyn PIC 50 external defibrillator/monitor SA060010 Boston Scientific Urovac bladder evacuator SA060011 Boston Scientific Carotid WALLSTENT endoprothesis with Monorail delivery system SA060012 Cook Malleable Tip Filiform, model or catalog # 110245 Cook Duette Multi Band Mucosectomy Kit, model or catalog # DT-6 Beckman Coulter UniCel DxC 600, 600i and 800 Synchron SA060014 Clinical Systems, model or catalog # A20463, A27331 and A29764 Coopersurgical 60cc Handy-Vak Locking Syringe, model or SA060015 catalog # MX 500 Bio-Rad Laboratories Diagnostics Group Liquichek Pediatric SA060016 Control, model or catalog # 353X, 354 and 355 SA060013 SA060017 Plus Orthopedics Femoral Clamp TKR (slim) SA060018 SA060019 SA060020 SA060021 SA060022 SA060023 SA060024 SA060025 Gyrus ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK MDS Nordion Theratron 780C, 780E, 1000, 1000E, Phoenix, Elite 80 and Elite 100 Cobalt Radiotherapies Terang Nusa Sterile Triumph LT Latex Powder-Free Surgeons Gloves, lot number T502504322 ArthroCare OPUS Smartstitch Suture Cartridge (catalog number OM-8071) and Smartstitch Magnum Wire Suture Cartridge (catalog number OM-8075) Sorenson Medical ambIT Ambulatory Infusion Therapy Intermittent Pump, catalog number 220245 Southmedic Vapofils with Stainless Steel Block Ends, Item Numbers V0507F (Isoflurane) and V0507S (Sevofluane) Respironics NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), model number 1025310 Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09 SA060026 Siemens 3D-I/III Ceiling Stand, Diagnostic x-ray tube mount SA060027 Cardinal Health Extension Set Model G304020M and G400200B SA060028 Hand pendants of Varian C-Series Clinac linear accelerators Medical Device Control Office Agent Contact Telephone No. 2960 7117 Remarks The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. FDA Z-1156-06 Class II Recall 2006/07/05 Solar Medical Ltd. 2425 0926 FDA Z-1160-06 Class II Recall 2006/07/05 N/A N/A FDA Z-1161-06 Class II Recall 2006/07/05 BioMerieux China Limited 2356 7033 The local agent informed that no affected units had been distributed in Hong Kong. FDA Z-1162-06 Class II Recall 2006/07/05 Leica Microsystems Ltd. (Hong Kong) 2564 6699 3 affected units in Hong Kong. FDA Z-1163-06 Class II Recall 2006/07/05 B. Braun Medical (Hong Kong) Ltd. 2277 6125 FDA Z-1164-06 to Z-1168-06 Class II Recall 2006/07/05 St. Jude Medical (Hong Kong) Ltd. 2996 7601 FDA Z-1176-06 Class II Recall 2006/07/05 Roche Diagnostics (Hong Kong) Limited 2485 7555 FDA Z-1195-06 Class I Recall 2006/07/07 N/A N/A 2006/07/07 Boston Scientific Hong Kong Ltd. 2960 7117 2006/07/08 Boston Scientific Hong Kong Ltd. 2960 7117 Boston Scientific Hong Kong Ltd. Boston Scientific Hong Kong Ltd. N/A N/A Urgent Medical Device Recall Urgent Medical Device Recall (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 A.R. Burkhill & Sons (Hong Kong) 1041 Ltd. (1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2) 2541 A.R. Burkhill & Sons (Hong Kong) 1041 Ltd. Health Canada 31746 Type II Recall 2006/07/10 Health Canada 31750 Type II Recall 2006/07/10 Health Canada 31742 Type II Recall 2006/07/10 Beckman Coulter Hong Kong Ltd. 2240 6260 Health Canada 30621 Type II Recall 2006/07/10 N/A N/A Health Canada 31622 Type II Recall 2006/07/10 Bio-Rad Pacific Ltd. 2789 3300 MHRA 2006/006/022/291/010 Field Safety Corrective Action 2006/07/10 N/A N/A FDA Z-1175-06 Class II Recall 2006/07/12 N/A N/A FDA Z-1178-06 to Z-1184-06 Class II Recall 2006/07/12 MDS Nordion (Hong Kong) 2827 8666 FDA Z-1185-06 Class II Recall 2006/07/12 N/A N/A FDA Z-1186-06 & Z-1187-06 Class II Recall 2006/07/12 N/A N/A FDA Z-1188-06 Class II Recall 2006/07/12 N/A N/A FDA Z-1189-06 & Z-1190-06 Class II Recall 2006/07/12 N/A N/A FDA Z-1191-06 Class II Recall 2006/07/12 Celki Medical Company 2268 9228 FDA Z-1202-06 Class II Recall 2006/07/12 Suburfarm Investment & Trading Co. Ltd. 2780 9421 FDA Z-1205-06 Class II Recall 2006/07/12 Siemens Medical Solutions Ltd. 2870 7533 MHRA 2006/007/010/291/024 Field Safety Corrective Action 2006/07/12 N/A N/A FDA Z-1206-06 Class II Recall 2006/07/12 Varian Medical Systems Pacific Inc. 2724 2836 119 The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 35 units of the affected models previously supplied in Hong Kong. 149 affected units in Hong Kong. The local agents informed that no affected units had been distributed in Hong Kong. The local agents informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent has informed all affected users. No product recall was necessary. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. 2 affected units in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong. Department of Health The Government of HKSAR SA060029 Disetronic D-TRONplus power packs used in D-TRONplus insulin pumps SA060030 Rocket Sekdubger Chest Drainage Set FDA MHRA N/A 2006/007/003/291/024 Firm Press Release Field Safety Corrective Action Urgent Medical Device Recall Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 2006/07/13 Roche Diagnostics (Hong Kong) Limited 2485 7597 2006/07/13 N/A N/A 2006/07/14 Boston Scientific Hong Kong Ltd. 2960 7117 2006/07/14 N/A N/A 2006/07/14 N/A N/A 2006/07/14 N/A N/A Boston Scientific Hong Kong Ltd. N/A SA060032 Bio Stat Gentamicin Calibrator MHRA 2006/006/016/401/017 SA060033 Joint Replacement Instrumentation Ltd. Brill Bit MHRA 2006/007/003/291/014 MHRA 2006/007/013/081/004 MHRA 2006/007/013/291/004 2006/07/17 Baxter Healthcare Ltd. 2807 8556 FDA Z-1196-06 Class II Recall 2006/07/19 GE Medical Systems Hong Kong Ltd. 2783 1838 FDA Z-1207-06 to Z-1211-06 Class II Recall 2006/07/19 N/A N/A FDA Z-1212-06 Class II Recall 2006/07/19 N/A N/A FDA Z-1219-06 to Z-1221-06 Class II Recall 2006/07/19 N/A N/A FDA Z-1222-06 Class II Recall 2006/07/19 N/A N/A Class II Recall 2006/07/19 N/A N/A 2006/07/19 N/A N/A SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece kit SA060034 Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot 52F5 SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit SA060036 SA060037 SA060038 SA060039 SA060040 SA060041 GE Healthcare S/5 Anesthesia Delivery Unit Fresh Gas Control (A-FGC1) Unit Sammons Preston Rolyan ValueLine and Midland Mat Platforms, various models Vanguard Medical Concepts Reprocessed Ethicon Bladeless Trocars, model 35NLT, 35NST, 35OL Kensey Nash TriActiv System Procedure Kit and Balloon Inflation Syringe International Biophysics Corporation (IBC) Suction Handle (Sterile), part # 1990S International Biophysics Corporation (IBC) FloProbe (Nonsterile), part # 3080N SA060042 Bard 8F Bard Channel Steerable Shealth SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator Medtronic Model 8731 intrathecal catheters and model 8598 intrathecal catheter distal revision kits Cardinal Health (formerly known as ALARIS) IVAC P4000 SA060045 Syringe pump SA060044 FDA Z-1223-06 MHRA 2006/007/017/601/173 Medtronic International, Ltd. N/A FDA N/A Field Safety Corrective Action Voluntary Field Corrective Action Urgent: Worldwide Medical Device Recall 2006/07/19 Medtronic International, Ltd. 2919 1355 2006/07/21 Medtronic International, Ltd. 2919 1362 The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. 31 affected units in Hong Kong. Rectification completed. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. MHRA MDA/2006/042 Action 2006/07/24 N/A N/A SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329 Health Canada 28894 Type II Recall 2006/07/24 Novartis Pharmaceuticals (HK) Ltd. 2881 4235 SA060047 Oxoid Imipenem 10ug Discs Health Canada 31477 Type II Recall 2006/07/24 South East Chemicals & Instruments Ltd. 2802 6333 106 units distributed in Hong Kong. Health Canada 31861 Type II Recall 2006/07/24 Terumo China (H.K.) Ltd. 2866 0811 The local agent informed that no affected units had been distributed in Hong Kong. Health Canada Terumo Cardiovascular Systems Advanced Perfusion System 1-Centrifugal and 1-Roller Pump Bellco Formula, Formula 2000, Formula 2000 Domus, Formula SA060049 2000 Plus and Formula 2000 Plus Domus Hemodialysis SA060048 31353 Type II Recall 2006/07/24 N/A N/A Boston Scientific Hong Kong Ltd. N/A Urgent Medical Device Recall 2006/07/25 Boston Scientific Hong Kong Ltd. 2960 7117 Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle SA060051 - Stubby/Short, catalog number 004413300 FDA Z-1225-06 Class II Recall 2006/07/26 N/A N/A SA060052 Smith & Nephew TriVex Resector Kits, various models FDA Z-1226-06 to Z-1229-06 Class II Recall 2006/07/26 Smith & Nephew Healthcare Ltd. 2645 8703 SA060053 Smith & Nephew Dyonics Electroblade 4.5, various models FDA Z-1230-06 to Z-1233-06 Class II Recall 2006/07/26 Smith & Nephew Healthcare Ltd. 2645 8703 SA060054 3M Nexcare First Aid High Performance Gauze Pad FDA Z-1234-06 Class II Recall 2006/07/26 3M Hong Kong Ltd. 2806 6314 SA060055 Gore Tag Thoracic Endoprosthesis Systems FDA Z-1236-06 & Z-1237-06 Class II Recall 2006/07/26 W.L. Gore & Associates (Hong Kong) Limited 2622 9622 Aksys PHD Personal Hemodialysis System for daily home SA060056 hemodialysis, Model 1M101 FDA Z-1239-06 Class II Recall 2006/07/26 N/A N/A SA060057 Cordis INFINITI 6 French Diagnostic Catheter FDA Z-1240-06 Class II Recall 2006/07/26 Johnson & Johnson (Medical) Hong Kong Ltd. 2738 6080 Class II Recall 2006/07/26 Instrumentation Laboratory Ltd. 2792 7773 2006/07/26 Abbott Laboratories Ltd. 2806 4201 2006/07/26 Olympus Hong Kong Ltd. 2376 1805 2 SA060050 Boston Scientific Cutting Balloon Ultra Monorail Device Instrumentation Laboratory HemosIL and Hemoliance RecombiPlasTin, Prothrombin Time Test Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02, SA060059 Lot Number: J156610 and J156710 Olympus Life and Material Science Europa GmbH SA060060 Immunoglobulin M, OSR6146 SA060058 Medical Device Control Office FDA Z-1246-06 & Z-1247-06 MHRA 2006/006/029/291/002 MHRA 2006/005/015/291/003 Field Safety Corrective Action Field Safety Corrective Action 120 The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. Department of Health The Government of HKSAR Cordis SV-5 and SV-8 Peripheral Steerable Guidewires Catalog 503-558, 503-558X, 503-658, 503-658X (41 specific lots only) Baxa Ltd. Reusable enteral feeding dispenser 50ml for SA060062 attachement to female oral ports Potasium electrode for Roche Hitachi 917 Modular Analytics, SA060063 Lot number L33 and L99 and all M lots Beckman Coulter Cytomics FC 500 Flow Cytometers System SA060064 with CXP Software versions: 2.0 and 2.1 SA060061 Medical Device Control Office MHRA 2006/007/026/081/004 MHRA 2006/007/025/291/014 MHRA 2006/007/021/081/003 MHRA 2006/007/028/291/004 Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action Field Safety Corrective Action 121 Johnson & Johnson Medical Hong Kong 2738 6080 2006/07/27 N/A N/A 2006/07/31 Roche Diagnostics (Hong Kong) Limited 2485 7597 2006/07/31 Beckman Coulter Hong Kong Ltd. 2240 6260 2006/07/27 The local agent informed that no affected units had been distributed in Hong Kong. The manufacturer informed that no affected units had been distributed in Hong Kong. The local agent informed that no affected units had been distributed in Hong Kong. With affected units in Hong Kong. Department of Health The Government of HKSAR

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