Major Safety Alerts in 2014 - Apr
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 Mar 2014 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
Date of Issue
Description of Product
(YYYY/MM/D
Siemens Digital Linear Accelerators of type PRIMUS, ONCOR and ARTISTE 2014/04/01
550 TxT Treatment Table
Stryker InterPulse Handpiece with succion [Catalogue Numbers: 0210-1102014/04/01
000; 0210-114-000; 0210-114-100]
2014/04/01 Temena SAS USB and USC needles [Article number: USB050-22 and
USC050-22]
Air
Liquide Medical Systems Ventilators Monnal T50, T50JP, T50DE, T40 and
2014/04/01
T40DE
Alere Alere Triage BNP Test for the Beckman Coulter Access Family of
2014/04/01
Immunoassay Systems (Reagent Pack lots 329599, K329599 and K331265)
Biomet Comprehensive Nano Humeral Component PPS (Part Numbers:
2014/04/01
115730, 115732, 115734, 115736, 115738, 115740)
Ortho Clinical Diagnostics (OCD) enGen Laboratory Automation Systems
2014/04/01 configured with Data Innovations, LLC Instrument Manager (IM) v8.06
2014/04/01
2014/04/01
2014/04/01
2014/04/01
Draeger Medical Ondal AC2000 spring-loaded arm
GE Healthcare Innova 2100IQ, Innova 2121IQ, Innova 3100, Innova 3100IQ,
Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova IGS 620, Innova IGS 630
Cardiovascular X-ray imaging systems
Teleflex Medical Bondek Plus; STAINLESS STEEL Monofilament Suture
Teleflex Medical Dekna-lok Absorbable Surgical Suture (Model/Part no.:
BP1000V2L; Lot no.: 02C1003535; 02F1000711)
2014/04/01
Siemens Healthcare Diagnostics ADVIA Centaur Folate Assay
2014/04/01
2014/04/01
Handicare AB Wing handles for ReTurn7400 and ReTurn7500
Integra LifeSciences 1)SynPlug Cement Restrictor; 2)OptiPlug Cement
Restrictor
Baxter
Healthcare Colleague Volumetric Infusion Pumps (Product code:
2M91617 & 2M91637 )
2014/04/02
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
MHRA
2014/003/026/601/001
FSN
Siemens Healthcare
Diagnostic Limited
Agent Contact
Telephone No.
2870 7533 /
2870 7888
MHRA
2014/003/027/081/002
FSN
Stryker China Ltd
2518 6915
MHRA
2013/011/022/401/047
FSN
2014/003/027/081/001
FSN
N.A.
Air Liquide Medical
Systems
N.A.
MHRA
MHRA
2014/003/025/081/016
FSN
Alere San Diego, Inc.
N.A.
MHRA
2014/003/024/291/007
FSN
Biomet, Inc.
N.A.
MHRA
2014/003/024/601/009
FSN
Ortho Clinical
Diagnostics
2737 5736
MHRA
2014/003/027/081/010
FSN
Draeger Hong Kong
Limited
2877 3077
MHRA
2014/003/025/291/003
FSN
GE Medical Systems
Hong Kong Ltd.
2783 1838
MHRA
2014/003/027/291/005
FSN
N.A.
N.A.
MHRA
2014/003/024/081/005
FSN
N.A.
N.A.
TGA
RC-2014-RN-00369-1
Class III
MHRA
MHRA
2014/003/024/081/029
2014/003/024/291/002
FSN
FSN
Siemens Healthcare
Diagnostic Limited
N.A.
N.A.
2870 7533 /
2870 7888
N.A.
N.A.
TGA
RC-2014-RN-00384-1
Class II
Baxter Healthcare Ltd
2807 8516
2014/04/03
Philips ADAC Vertex Classic, Vertex Plus, Vertex V60 and Solus Systems
TGA
RC-2014-RN-00405-1
Class I
2014/04/03
Siemens ARTIS Zeego
TGA
RC-2014-RN-00383-1
Class II
2014/04/03
Philips DigitalDiagnost [Patient support for stitching]
Firm
NA
NA
2014/04/04
GE Healthcare OEC 9900 Workstation Monitor Spring Arm Screws
TGA
RC-2014-RN-00389-1
Class II
2014/04/04
Boston Scientific NovaGold Guidewire
2014/04/07
Omnitech Labs Omnilab Version 12
Wright Medical Technology Inc Lapidus Plate [Model no.:58510000, 58510001;
Lot no.: 1537061,1537182]
2014/04/07
Firm
NA
NA
Health Canada
RA-38661
Type II
Health Canada
RA-38659
Type II
N.A.
Philips Electronic Hong
2821 5364
Kong Ltd
Siemens Healthcare
2870 7533 /
Diagnostic Limited
2870 7888
Philips Electronic Hong
2821 5364
Kong Ltd
GE Medical Systems
2783 1838
Hong Kong Ltd.
Boston Scientific (Hong
2960 7139
Kong Ltd)
Omnitech Labs Inc
N.A.
Hong Kin Medical
(852) 23570397
Instrument Limited
2014/04/07
2014/04/07
Bionix Development Corporation A) Otoclear Ear Irrigation; B) Otoclear Ear
Irrigation System [Model no.: A) 7245; B) 7280; Lot no.: A) 7245; B) 7280]
GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima
MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products
2014/04/07
Solta Medical, Inc. Fraxel Dual 1550/1927 Laser Systems (Model no.: MCSYS-SR1500-D)
2014/04/07
Siemens Axiom Vertix MD Trauma
2014/04/07
2014/04/08
2014/04/08
2014/04/08
2014/04/08
2014/04/08
2014/04/08
2014/04/08
2014/04/08
2014/04/08
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products NT-proBNP
Calibrators (Product Code: 6802157; Lot: 1110), VITROS Immunodiagnostic
Products NT-proBNP Reagent Pack (Product Code: 6802156; Lot 1110)
Dentalez, Inc. Endowel [Model no.: 20586X; All lots]
Xavant Technology (Pty) Ltd STIMPOD NMS450 Nerve Stimulator [PRODUCT
CODE: XT-45011, XT-45011-NA, XT-45001 and XT-45001-NA]
Xavant Technology (Pty) Ltd STIMPOD NMS410 / NMS450 Nerve Stimulator
[PRODUCT CODE: XT-41000, XT-41000-NA, XT-41001, XT-41001-NA, XT45011, XT-45011-NA, XT-45001, XT-45001-NA]
Advanced Sterilization Products (ASP) Tyvek Self-Seal Pouches with
STERRAD Chemical Indicator (Product Codes: 123XX, 124XX, 125XX)
Aspen Medical Surgidyne Saber Wound Drainage (Product Code: 310100,
310101, 332263)
Depuy Synthes Cortex Screw Stardrive Ø 1.5mm, Self-tapping, Length 8mm,
Stainless Steel, Sterile (Part No.: 02.214.108S; Lot No.: 8478643)
LINC Medical Open tip 2-way all silicone catheters (Model/Part no.: 08452210;
Lot no.: C33516; Expiry date: Jun 2015)
Integra Surfix Screw diameter 3.5mm length 22mm; and diameter 3.5mm
length 30mm (Model/Part no.: 285322S; 285330S; Lot no.: F6S6; F6ZL)
GE Healthcare Kenex suspension arm with radiation shield and/or surgical
lamp
Health Canada
RA-38675
Type II
N.A.
N.A.
TGA
RC-2014-RN-00385-1
Class I
GE Medical Systems
Hong Kong Ltd.
2783 1838
TGA
RC-2014-RN-00402-1
Class II
Solta Limited
Health Canada
RA-38681
Type II
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
Firm
CL2014-120ea
NA
Ortho Clinical
Diagnostics
2737 5736
Health Canada
RA-38671
Type II
N.A.
N.A.
MHRA
2014/003/031/081/015
FSN
N.A.
N.A.
MHRA
2014/003/031/291/013
FSN
N.A.
N.A.
MHRA
2014/003/028/291/001
FSN
MHRA
2014/004/003/081/030
FSN
MHRA
2014/004/001/081/039
FSN
MHRA
2013/011/008/401/012
FSN
N.A.
N.A.
MHRA
2014/004/002/081/007
FSN
N.A.
N.A.
TGA
RC-2014-RN-00407-1
Class I
2145 2533
2014/04/08
GE Healthcare Vivid E9 Systems with Software Versions 113.0.1 to 113.0.5
TGA
RC-2014-RN-00411-1
Class I
2014/04/08
2014/04/08
TGA
MHRA
RC-2014-RN-00415-1
2014/004/001/601/013
Class II
FSN
2014/04/09
Covidien Pipeline Embolization Device and Alligator Retrieval Device
Digitimer Ltd. Double lumen cystometry catheter, 8 Fr; DL cystometry Set, 8
Fr.
Philips Ingenuity Core (Software version: 3.5.5)
TGA
RC-2014-RN-00417-1
Class II
2014/04/09
Philips Healthcare HeartStart XL+ Defibrillator/Monitor [Model number 861290]
Firm
FSN86100139
NA
TGA
RC-2014-RN-00416-1
Class II
TGA
RC-2014-RN-00420-1
Class II
TGA
RC-2014-RN-00419-1
Class I
Firm
SB_RDC_2014_02
NA
TGA
RC-2014-RN-00422-1
Class I
TGA
RC-2014-RN-00423-1
Class II
2014/04/10
2014/04/10
2014/04/10
2014/04/10
2014/04/11
2014/04/11
Life Technologies Dynabeads HLA (Human Leucocyte Antigen) Class II
[Catalogue Number: 21004D; Lot Numbers: 135384110 (Expiry Date: 09/2014);
142281200 (Expiry Date: 02/2015)]
Siemens ACUSON X700 Ultrasound System with software versions 1.0.00,
1.0.01, 1.0.02, 1.1.00 or 1.1.02 [Catalogue/Lot number: 1065844]
B. Braun Cavafix (Article Code: 4152557, 4173350, 4173759; All batches)
Roche Diagnostics Accu-Chek Compact test strips and Accu-Chek Mobile
tests
Edwards Life Sciences Edwards Lifesciences Fem-Flex II Cannulae (Model
Numbers: FEMII016A, FEMII018A & FEMII020A; All Lot Numbers)
Abbott Laboratories Lipase Reagent
Johnson & Johnson
(Hong Kong) Ltd.
Aspen Medical Europe
Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
GE Medical Systems
Hong Kong Ltd.
GE Medical Systems
Hong Kong Ltd.
Covidien HK Ltd
N.A.
Philips Electronic Hong
Kong Ltd
Philips Electronic Hong
Kong Ltd
Thermo Fisher
Scientific
Siemens Healthcare
Diagnostic Limited
B. Braun Medical (H.K.)
Ltd.
Roche Diagnostics
(Hong Kong) Ltd
Goodman Medical
Supplies Ltd.
Abbott Laboratories Ltd.
2738 6080
N.A.
2738 6002
2783 1838
2783 1838
25743251
N.A.
2821 5364
2821 5364
2407 8450
2870 7533 /
2870 7888
2277 6162
2481 3387
2332 4455
2593 2211
2014/04/15
BioMerieux Mueller Hinton 2 Agar (Reference no.: 43301, 43302, 43309,
43511, 41864, 51075; Lot no.: All)
3M Company - Health Care Business 3M "Steri-Vac" Gas Sterilizer/Aerators,
Model no.: 4XL,5XL, 8XL
Merit Medical Systems, Inc. A) Pressure Monitoring Tubing; B) Merit Custom
Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO
[Model no.: A) PM6006; B) K02-01010A; Lot no.: A) H591335; B) H574228]
Covidien EverCross .035" OTW PTA Catheter
Alcon LenSx Laser System (Serial numbers: 0611-A020, 0711-A022, 1011A053, 1011-A060, 0312-A123)
Varian Medical Systems C-Series Clinac Models; 600C, 600CD, 6EX, DBX,
2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x
Philips Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT
SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and
MX8000 Dual v. EXP
Bionic Medizintechnik GmbH Bionic Comfortline Chair [Serial numbers starting
from 06C06-018; Model number: 109434, 110014, 110015, 113789, 114665,
LOC-17039, LOC-17070, LOC-17097, LOC-17119, NVM-10336]
Stryker Instruments Penadapt [Model number: 0702-045-027]
2014/04/15
Irvine Biomedical, Inc. 1500T14 Cardiac Ablation System - Generator
Health Canada
RA-39031
Type II
2014/04/15
Biosense Webstar THERMOCOOL SF NAV Diagnostic/Ablation Deflectable
Tip Catheter
MHRA
2014/004/007/291/013
FSN
2014/04/15
Depuy Synthes GLOBAL APG+ 2.5mm Breakaway Guide Pin (223000019)
MHRA
2014/004/007/081/010
FSN
2014/04/15
MHRA
2014/004/008/081/040
FSN
MHRA
2014/004/007/081/003
FSN
Chindex
N.A.
MHRA
2014/004/007/081/002
FSN
Ortho Solutions
N.A.
MHRA
2014/004/004/601/006
FSN
2014/04/15
Hain LifeScience Analyzer 1.1.1 of FluoroType MRSA Kit
Intuitive Surgical 5mm Curved Cannula for Single-Site Instruments (used with
the da Vinci Si Surgical System)
Ortho Solutions OS315060 8.0mm x 60mm Titanium Cann. Cancellous Screw
18mm Thread (Lot: 01003297)
Siemens AXIOM Artis, Artis zee or Artis Q system in conjunction with a
wireless footswitch
Medtronic Potential for Occluded Extension Tubing in Refill Kits
Stryker China Ltd
St. Jude Medical (Hong
Kong) Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
bioMerieux China Ltd.
TGA
RC-2014-RN-00432-1
Class II
2014/04/15
Smith & Nephew Inc TRIGEN INTERTAN Nails
MHRA
2014/004/008/081/018
FSN
Siemens Healthcare
Diagnostic Limited
Medtronic International
Ltd
Smith & Nephew Ltd.
2014/04/15
Vidacare Corporation ( subsidiary of Teleflex) EZ-LO 45 mm Needle Set
Beckman Coulter Inc A) Unicel DXH 800 Coulter Cellular Analysis System
[Catalogue number: 629029 & B24802; All lots]; B) Unicel DXH 600 Coulter
Cellular Analysis System [Catalogue number: B23858 ; All lots]
Zimmer Trabecular Metal Acetabular Shell (Lot or serial number: 62490588;
Model or catalog number: 00-6202-060-22)
Fisher & Paykel Healthcare Limited Infant Nasal Continuous positive airway
pressure (CPAP) Prongs and Bubble CPAP Starter Kits
Health Canada
RA-39043
Type II
N.A.
2870 7533 /
2870 7888
29191362
2648 7700 /
2645 8706
N.A.
Health Canada
RA-39079
Type II
Beckman Coulter Hong
Kong Ltd
Health Canada
RA-39101
Type II
2014/04/11
2014/04/14
2014/04/14
2014/04/14
2014/04/14
2014/04/14
2014/04/14
2014/04/15
2014/04/15
2014/04/15
2014/04/15
2014/04/16
2014/04/16
2014/04/16
Firm
NA
NA
bioMerieux China Ltd.
2195 9302
FDA
Z-1318-2014
Class II
3M Hong Kong
2806 6132
FDA
Z-1319-2014 to Z-1320-2014
Class II
Merit Medical Asia
22076810
TGA
RC-2014-RN-00431-1
Class II
Covidien HK Ltd
25743251
TGA
RC-2014-RN-00424-1
Class II
Alcon Hong Kong, Ltd.
25680636
Firm
CP-06611
NA
Varian Medical
Systems Pacific Inc.
2724 2836
Firm
FSN # 72800614
NA
Philips Electronic Hong
Kong Ltd
2821 5364
Health Canada
RA-39025
Type II
N.A.
N.A.
Health Canada
RA-39021
Type II
2518 6915
TGA
RC-2014-RN-00437-1
Class I
Zimmer PTE Ltd. (Hong
Kong branch)
Fisher & Paykel
Healthcare Limited
GE Medical Systems
Hong Kong Ltd.
BrainLAB Ltd
29967688
2738 6002
2738 6002
2195 9302
N.A.
2992 0968
2116 0032 /
9171 8323
2014/04/17
GE Healthcare Centricity PACS RA1000 Workstation versions 3.2 and higher
TGA
RC-2014-RN-00442-1
Class II
2014/04/17
Brainlab ExacTrac 5.5.5
Spacelabs Healthcare Inc. ARKON Anesthesia Delivery System with Version
2.0 Software
Hospira Nonvented Y-set for transurethral resection (List number: 06543-01)
TGA
RC-2014-RN-00439-1
Class I
FDA
NA
Class I
N.A.
N.A.
Firm
NA
NA
Hospira Limited
2898 2886
2014/04/17
2014/04/17
2783 1838
2417 1881
2014/04/22
GE Healthcare Panda iRes Warmers integrated with Nellcor SpO2
TGA
RC-2014-RN-00450-1
Class I
2014/04/22
Philips Healthcare MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x
TGA
RC-2014-RN-00462-1
Class I
2014/04/22
Thermo Fisher Scientific Mueller Hinton-HTM (culture media) [Batch Number:
1294381] Ltd SOMATOM Emotion 6 / 16 Slice Configuration and SOMATOM
Siemens
Spirit/Spirit Power Systems [Catalogue numbers: 10045692, 10165566,
10165888, 10165977, 10415118, 10415119, 10415116 & 10415117]
Siemens Ltd syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration
[Lot number: 10091970]
Siemens Healthcare Diagnostics ADVIA Centaur, ADVIA Centaur XP and
ADVIA Centaur CP
Model: 1) ADVIA Centaur Systems TSH3 Ultra 100T, 500T; 2) ADVIA Centaur
Systems VitD 100T, 500T; 3) ADVIA Centaur BRAHMS PCT 100T
TGA
RC-2014-RN-00454-1
Class II
2014/04/22
2014/04/22
GE Medical Systems
Hong Kong Ltd.
Philips Electronic Hong
Kong Ltd
Thermo Fisher
Scientific
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
2783 1838
2821 5364
2407 8450
TGA
RC-2014-RN-00457-1
Class I
TGA
RC-2014-RN-00425-1
Class I
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
TGA
RC-2014-RN-00441-1
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
Siemens Ltd Luminos dRF ; Catalogue number: 10094200
TGA
RC-2014-RN-00456-1
Class I
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
2014/04/22
Baxter Healthcare FOLFusor SV 0.5 ml/hr (Product code: 2C4700K; All lot
numbers up to and including 14B039 )
TGA
RC-2014-RN-00447-1
Class II
Baxter Healthcare Ltd
2807 8516
2014/04/23
Siemens Ltd syngo Imaging
MHRA
2014/004/014/601/007
FSN
2014/04/23
2014/04/23
MHRA
MHRA
2013/011/007/401/002
2014/004/015/291/026
FSN
FSN
2870 7533 /
2870 7888
N.A.
N.A.
MHRA
2014/004/011/601/001
FSN
Ortho Clinical
Diagnostics
2737 5736
MHRA
2014/003/019/601/002
FSN
MHRA
2014/004/015/291/001
FSN
MHRA
2014/004/011/601/004
FSN
MHRA
2014/004/010/081/018
FSN
Firm
FCA-2014-026_HK
NA
Baxter Healthcare Ltd
2807 8516
2014/04/25
Quest 88 Seating kits for W2 size Kaye Walkers
Ottobock 1) A200 Power Wheelchair; 2) Skippi / Skippi Plus Power Wheel
chair Clinical Diagnostics (OCD) enGen Laboratory Automation Systems
Ortho
(enGen) with TCAutomation Software v2.6, v3.2 and v3.5 Configured with
Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh
B. Braun Melsungen COROFLEX BLUE NEO 2.75X16MM (Product Code:
5029032; Batch No.: 13G01809)
Cochlear Baha Soft Tissue Gauge 6 mm (Part No.: 95070)
Global Components Medical TIVA sets (GCM-1003, GCM-223, GCM-223B,
GCM-253, GCM-253B, GCM-303B, GCM-304, GCM-SPCA)
MicroPort Orthopedics PROFEMUR Modular Neck Extraction Plug (Part No.:
PRNEPLLN, PRNEPLSH; Lot No.: 1221430, 1221430, 1306330)
Baxter Healthcare Peritoneal Dialysis Transfer Sets, Titanium Adapters,
Disconnect Caps and Clamshells
Elekta HexaPOD evo RT Couchtop Securing Screws
Siemens Healthcare
Diagnostic Limited
N.A.
N.A.
TGA
RC-2014-RN-00468-1
Class I
Terumo CVS Sarns Disposable Centrifugal Pump
Firm
MD-2014-001-R
NA
Elekta Ltd
Terumo China (Hong
Kong) Ltd.
2891 2208
2014/04/25
TGA
RC-2014-RN-00478-1
Class I
Johnson & Johnson
(Hong Kong) Ltd.
2738 6002
TGA
RC-2014-RN-00479-1
Class II
FUJIFILM (Hong Kong)
Limited
N.A.
TGA
RC-2014-RN-00464-2
Class I
GE Medical Systems
Hong Kong Ltd.
2783 1838
TGA
RC-2014-RN-00476-1
Class I
TGA
RC-2014-RN-00474-1
Class I
2014/04/22
2014/04/22
2014/04/23
2014/04/23
2014/04/23
2014/04/23
2014/04/23
2014/04/23
2014/04/28
2014/04/28
2014/04/28
2014/04/28
2014/04/28
Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies
and BC Distractor Bodies) (Part Number: 04.315.063, Lot Number: 6883301;
Part Number: 04.315.066, Lot Number: 7082908; Part Number: 04.315.068,
Lot Numbers: 7266969 & IS10386)
FUJIFILM FDR-1000AWS / FDR-2000AWS / FDR-3000AWS V5.1 with Biopsy
unit [Serial Number: 37020038]
GE Healthcare Discovery MR450w, Discovery MR750, Optima MR450w,
Optima MR450w equipped with the GEM option, Discovery MR750w and
Discovery MR750w equipped with the GEM option products
Leica Biosystems Bond Ready-To-Use Primary Antibody Thyroglobulin (1D4);
Code no.: PA0025; Lot no.: 24963
Philips Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core,
Ingenuity Core128, Ingenuity Flex
B. Braun Medical (H.K.)
Ltd.
Cochlear (Hong Kong)
Ltd
Global Components
Medical Ltd
MicroPort Orthopedics
BV
2277 6162
2530 5773
N.A.
N.A.
2866 0811
Leica Microsystems 2963 8037/2564
Ltd.
6699
Philips Electronic Hong
2821 5364
Kong Ltd
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
2014/04/29
Philips HeartStart XL+, Defibrillator/Monitor [Model number 861290;
Manufactured by Philips between November, 2013 and December, 2013]
Standard Diagnostics Panbio Leptospira IgM ELISA [Cat. No.: 02PE10; Lot
No.: 261004(subcode : A and/or B)]
Teleflex Medical Nebulizers [Various models]
Acumed Tension Band Pins
Agfa HealthCare IMPAX Clinical Applications software version 3.0 (build
5.0.48.0)
Blue Belt Technologies NavioPFS system (Catalogue No.: NPFS-02000, NPFS
02010, NPFS-02020)
Cardiocom LLC Cardiocom Commander FLEX UK power supply
Codman Neuro, DePuy Synthes non-implanted Medstream® Programmable
Infusion Pumps
HOYA CORPORATION PENTAX PENTAX Ultrasound Video Gastroscopes
EG-3830UT, EG-3630U and PENTAX Ultrasound Fibre Gastroscope FG-36UX
Maquet a) SERVO-U and b) SERVO-n (Article no.: a) 66 94 800; b) 66 88 600;
Software version: 1.00.05)
MHRA
2014/004/024/081/022
FSN
Philips Electronic Hong
Kong Ltd
2821 5364
MHRA
2014/004/017/601/006
FSN
N.A.
N.A.
MHRA
MHRA
2014/004/016/081/016
2014/004/023/081/031
FSN
FSN
N.A.
N.A.
MHRA
2014/003/017/081/024
FSN
N.A.
Acumed Ltd
Agfa HealthCare Hong
Kong Ltd
MHRA
2014/004/016/081/007
FSN
Blue Belt Technologies
N.A.
MHRA
2014/004/017/081/019
FSN
N.A.
MHRA
2014/004/022/081/029
FSN
MHRA
2014/004/016/081/006
FSN
MHRA
2014/004/022/081/013
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
Pentax Medical
Singapore Pte. Ltd
MAQUET Hong Kong
Limited
FSN
2014/04/30
Shasta Technologies GenStrip (Manufactured and distributed since Mar 2013)
FDA
NA
2014/04/30
Laparoscopic power morcellators
Arrow International Inc (Mayo Healthcare Pty Ltd– Sponsor in Australia)
Percutaneous Sheath Introducer Kits
Batch no.: AK09903A - 23F13G0162; SI09903E – RF3064915, RF3064710
TGA
NA
Safety
Communication
Alert
TGA
RC-2014-RN-00473-1
Class I
2014/04/30
2873 9321
2738 6080
N.A.
2207 6111
N.A.
N.A.
N.A.
N.A.
N.A.
N.A.