Major Safety Alerts in September 2008 (This page is subject to

Transcription

Major Safety Alerts in September 2008 (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 September 2008 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
Agent Contact
Source of
Reference No. by
MDCO Ref. No.
Description of Product
Alert Type by Source
Local Agent
Telephone No.
Source
(YYYY/MM/DD)
Information*
Teleflex Weck Clips products : Hemolok clips,
Solar-med Limited
N/A
Firm Initiated Field Action 2008/09/12
Solar-med Limited
2425 0926
Horizon Clips and Hemoclip
Johnson and Johnson ASP Automatic Endoscope Johnson & Johnson
Johnson & Johnson
N/A
Firm Initiated Field Action 2008/09/17
2738 6027
Reprocessor (AER)
Medical (HK)
Medical (HK)
al Device Safety Alerts - August 2008
s and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Source of
Information*
Reference No. by Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
2814 4836
SN080801
Bayer Ascensia Contour blood glucose meters
MHRA
MDA/2008/059
MDA
2008/08/01
Bayer Healthcare
SN080802
Levitronix CentriMag Systems
MHRA
2008/002/026/401/001
FSCA
2008/08/01
N/A
N/A
SN080803
Stryker Scorpio Series 7000 Tibial Impactor/Extractor
MHRA
2008/007/007/061/017
FSCA
2008/08/01
Stryker China Ltd
2518 6915
SN080804
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
2807 8500
2008/08/05
N/A
N/A
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
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
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
SN080819
Johnson and Johnson Depu Delta XTEND
MHRA
2008/007/023/061/004
FSCA
2008/08/11
Johnson & Johnson Medical Hong
Kong
2738 2818
SN080820
Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric
Infusion Pumps
MHRA
2008/007/022/051/006
FSCA
2008/08/13
N/A
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
Medical Device Control Office
2
Department of Health
The Government of HKSAR
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
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
2876 7525
SN080830
Philips Digital Diagnost
Health Canada
43190
Type II
2008/08/13
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
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
2722 8123
2783 1838
SN080841
Apline Microtargeting Electrode Cable
Apline BioMed
N/A
Varian Medical
Systems Pacific Inc.
N/A
Action
Action
SN080842
Varian Exact Couch Pinch Point
SN080843
GE Healthcare Solar 8000/i/M
MHRA
2008/007/024/601/510
FSCA
2008/08/18
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
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
3
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
SN080852
Roche Diagnostics modular analytics
MHRA
2008/007/011/061/012
FSCA
2008/08/20
Roche Diagnotics (Hong Kong) Ltd.
2485 7510
SN080853
Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute
Renal Therapy
Health Canada
N/A
N/A
2008/08/20
2807 8500
SN080854
Chiron PROCLEIX (Assay Reagent)
Press
N/A
N/A
2008/08/21
Chiron Limited
2161 3104
SN080855
ArthroCare Topaz XL ArthroWand
MHRA
2008/008/001/061/001
FSCA
2008/08/21
N/A
N/A
SN080856
MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator
MHRA
2008/008/004/051/010
FSCA
2008/08/21
2919 1300
SN080857
Smiths Medical CADD-MS 3 Ambulatory Infusion Pimp (Model 7400)
FDA
Z-1621-2008
Class II
2008/08/21
Goodman Medical Supplies Ltd
2332 4455
SN080858
Philips Medical Systems iSite PACS version 3.6.28.0 and version
4.1.17.0
FDA
Z-1443-2008 to Z-1444-2008
Class II
2008/08/21
Philips Medical Systems
2821 5480
SN080859
Varian Medical Systems On-Board Imager, versions 1.0.15 and
1.2.05 Imaging Accessory to Medical Linear Accelerator
FDA
Z-1442-2008
Class II
2008/08/21
2722 8123
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
FDA
Z-1525-2008
Class II
2008/08/21
BD Asia Ltd (Hong Kong)
2722 5660
FDA
Z-1527-2008
Z1527-2008 to Z-1528-2008
Class II
2008/08/21
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
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
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
2722 8123
SN080868
Maquet Expiratory Valve Coils
MHRA
2008/007/016/061/004
FSCA
2008/08/25
2393 9511
SN080869
GE Healthcare CT/SPECT Studies of Brain Scans
MHRA
2008/008/011/051/011
FSCA
2008/08/25
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
2575 8668
SN080860
SN080861
SN080862
4
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
2876 7525
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
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
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
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
y
Omnifit EON Surgical
g
Protocol
FDA
Z-1750-2008
Class II
2008/08/28
Stryker
y
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
SN080898
Medline Bariatric Wheelchair
FDA
Z-1770-2008 to Z-1772-2008
Class II
2008/08/28
N/A
N/A
SN080899
EKOS EndoWave Infusion System
FDA
Z-1773-2008
Class II
2008/08/28
N/A
N/A
SN080900
FDA
Z-2140-2008
Class II
2008/08/28
N/A
N/A
SN080901
Acumed Osteo-Clage Cable System Package Assembly (01-0001S)
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
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
2919 1300
SN080907
Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal
Dialysis System
MHRA
2008/005/028/061/023
FSCA
2008/08/29
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
2876 7525
5
SN080910
GE Voluson E8 Ultrasound Systems
MHRA
2008/005/019/601/350
FSCA
2008/08/29
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
6
Monthly Summary of Medical Device Safety Alerts - July 2008
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SN080701
Invacare Action³ manual wheelchair
MHRA
MDA/2008/044
MDA
2008/07/02
N/A
N/A
SN080702
Abbott Diagnostics ARCHITECT c8000 System
MHRA
2008/006/002/601/380
FSCA
2008/07/02
2806 4021
SN080703
Anspach Sterile Single-use Cuting Burrs
MHRA
2008/006/011/291/004
FSCA
2008/07/02
N/A
N/A
SN080704
Arrow International Cannon catheter , Cannon catheter II and Edge
catheter
MHRA
2008/006/018/061/010
FSCA
2008/07/02
N/A
N/A
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
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
2555 9421
SN080718
AGFA IMPAX 6.2.1 Network Gateway Server, License Key (Catalog
# ABC)
FDA
Z-1306-2008
Class II
2008/07/03
2555 9421
SN080719
Boston Scientific Lumenis/Slimline Fiber Strippers
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/07/03
Boston Scientific Hong Kong Ltd
2960 7136
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
2332 4455
N/A
Action
2008/07/07
Alcon Hong Kong Ltd
2161 0844
2008/001/010/401/007
FSCA
2008/07/07
N/A
N/A
SN080724
SN080725
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
7
SN080726
Draeger Medical Intensive Care ventilators
MHRA
2008/006/025/181/011
FSCA
2008/07/07
SN080727
TherapostureTheracare Beds supplied with Mesh Linked Padded
Rails
MHRA
2007/009/027/401/001
FSCA
2008/07/07
N/A
N/A
SN080728
Medtronic SynchroMed® II Implantable Infusion Pump
MHRA
2008/005/029/291/001
FSCA
2008/07/07
2919 1300
SN080729
Liko AB Universal SlingBar
MHRA
2008/006/024/071/002
FSCA
2008/07/07
N/A
N/A
SN080730
Invacare Harrier Heavy Duty (HD) battery powered wheelchair
MHRA
MDA/2008/050
MDA
2008/07/08
N/A
N/A
SN080731
Quest 88 Kaye Posture Control Walkers
MHRA
2007/011/015/401/003
FSCA
2008/07/08
N/A
N/A
SN080732
Steris Quick Connect (Model QXCXXXX)
Health Canada
38366
Type II
2008/07/10
Swedish Trading Co., Ltd
N/A
SN080733
Cardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack,
C) Sterile Cardiovascular Universal
Health Canada
39224
Type II
2008/07/10
Cardinal Health
N/A
SN080734
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
2783 1838
SN080737
Trinity Biotech D-Dimer High Control
Health Canada
41341
Type II
2008/07/10
N/A
N/A
Kong
2738 2818
SN080738
2877 3077
Cordis Smart Control Nitinol Stent System (Model C10040SL)
Health Canada
41441
Type II
2008/07/10
SN080739
Si
Siemens
AG M
Magicview
i i
300 (M
(Model
d l VA60A)
H lhC
Health
Canada
d
41521
Type
T
II
2008
2008/07/10
/07/10
Si
Siemens
Ltd.
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
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
2485 7510
SN080747
AGFA Drystar AXYS
Health Canada
42393
Type II
2008/07/10
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
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
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
8
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
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
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
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
SN080767
Boston Scientific Platinum PlusT Cononary Guidwire
MHRA
2008/007/001/061/022
FSCA
2008/07/14
Boston Scientific HK Ltd
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
2806 4021
SN080770
ArthroCare Covator Arthro Wand
MHRA
2008/004/016/401/009
FSCA
2008/07/16
N/A
N/A
2821 5480
MHRA
2008/007/003/061/008
FSCA
2008/07/17
Office ((Asia Pacific))
BD
N/A
Action
2008/07/21
2722 5660
CELKI Medical
Company
N/A
Action
2008/07/21
CELKI Medical Company
2268 9258
Kimal safety fistula needle
MHRA
MDA/2008/051
MDA
2008/07/22
N/A
N/A
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
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
2806 4021
SN080782
Beckman Coulter GEN.S and LH SlideMakers
MHRA
2008/007/002/601/459
FSCA
2008/07/24
2240 6150
SN080783
Roche cobas b 221 Software version 7.0
MHRA
2008/007/007/061/008
FSCA
2008/07/24
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
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
SN080771
Philips Medical Systems Biopsy Guide Starter Kits
SN080772
BD Vacutainer Blood Collection Tubes Containing Heparin
SN080773
Respironics PLV100 Ventilator (#RCA200802)
SN080774
SN080775
SN080776
9
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
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
2555 9421
SN080798
BD 60ml Luer-Lok Syringe (Recorder no. 309653)
BD
N/A
Action
2008/07/28
2722 5660
SN080799
Abbott Sequoia Spinal System Surgical Kits
FDA
Z-1479-2008
Class II
2008/07/28
2806 4021
SN080800
Medtronic Intrathecal Catheter Pump Segment Revision Kit (Model
no 8596SC)
FDA
Z-1308-2008
Class II
2008/07/28
Medtronic International Ltd
2919 1300
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
SN080806
Abbott ARCHITECT AFP assay
MHRA
2008/007/011/601/482
FSCA
2008/07/28
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
SN080811
Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo
Test
Fresenius Injectomat 50ml syringe
SN080812
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
2821 5480
SN080813
Philips Axis and Irix Gamma Cameras
MHRA
SN080814
Beckman Coulter Acetaminophen Reagent
MHRA
2008/007/024/601/509
FSCA
2008/07/31
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
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
2008/007/014/061/004
10
SN080819
Philips A)Brilliance 64 Slice CT System-Main Unit, B) Brilliance CT
Computed Tomography System,
Health Canada
42936
Type II
2008/07/31
2821 5480
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
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
2783 1838
SN080823
Stryker Vertier Surgical Tables
Health Canada
43004
Type II
2008/07/31
Stryker China Ltd
2518 6915
SN080824
Gambro Bioline, Hermoline
Health Canada
42406
Type II
2008/07/31
Gambro Hong Kong Ltd
2839 7010
SN080825
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
42939
Type II
2008/07/31
Stryker China Ltd
2518 6915
Health Canada
42974
Type II
2008/07/31
2783 1838
Health Canada
42906
Type II
2008/07/31
2839 7010
SN080828
Philips A) Prism 1000S, B) Prism 1000XP, C) Prism 2000S, D)
Prism 2000XP
Health Canada
32350
Type II
2008/07/31
2821 5480
SN080829
Maquet Cardipulmonary AG Remote Control
Control Unit
Unit (Model
(Model 939401)
Health Canada
41063
Type II
2008/07/31
2393 9511
SN080830
Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 005069-052-00)
Health Canada
43002
Type II
2008/07/31
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
2722 5660
SN080826
SN080827
11
Monthly Summary of Medical Device Safety Alerts -June 2008
MDCO Ref.
No.
SN080602
Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and
1 2)
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
Stryker Kinemax Plus Revision TS Tibial Insert
SN080608
SN080609
Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E6903)
AGA Medical Amplatzer PFO Occluder
SN080610
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Bausch and Lomb
N/A
Local Agent
Agent Contact
Telephone No
Firm Initiated Field Action
2008/06/02
Baush and Lomb
2213 3371
Boston Scientific
Hong Kong Ltd
MHRA
MHRA
MHRA
Affaps
N/A
2008/06/02
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
MHRA
2008/005/009/121/006
FSCA
2008/06/04
Stryker China Ltd
2518 6988
Health Canada
42116
Type II
2008/06/05
2806 4021
Health Canada
41996
Type II
2008/06/05
AGA Medical Corporation (Asia Pacific)
N/A
Arrow Balloon Temporary Pacing Catheter Kit
Health Canada
41991
Type II
2008/06/05
N/A
N/A
SN080611
BHM Ergiscake Scake abd Swivel Bar
Health Canada
41995
Type II
2008/06/05
Arjo Far East Ltd
2508 9553
SN080612
Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and
minipak
Health Canada
41858
Type II
2008/06/05
2789 3300
SN080613
Bio-Rad Varient B-Thalassemia Short Program
Health Canada
42066
Type II
2008/06/05
2789 3300
SN080614
Cardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack
and Othopedie-Fusion Posterieure
Health Canada
42115
Type II
2008/06/05
Cardinal Health
N/A
SN080615
Cook Hilal Embolization Coils
Health Canada
42174
Type II
2008/06/05
Cook Asia (Hong Kong) Ltd.
2781 0232
SN080616
Hill-Rom 100 Low Beds
Health Canada
41708
Type II
2008/06/05
N/A
N/A
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
N/A
N/A
Johnson and Johnson Depuy Lupine BR Anchor With Orthocord
Health Canada
42075
Type II
2008/06/05
2738 2818
Health Canada
42071
Type II
2008/06/05
Kong
Kong
Health Canada
40792
Type II
2008/06/05
2919 1300
N/A
SN080601
SN080618
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
2738 2818
SN080621
Nova Biomedical Statstrip Glucose Hospital Meter
Health Canada
42078
Type II
2008/06/05
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
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
N/A
N/A
SN080627
Roche Elecsys Progesterone II
Health Canada
41845
Type II
2008/06/05
2485 7510
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
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
12
SN080631
SN080632
Walter Lorenz Surgical Epker Osteotome (BOTH Slightly Curved
and Straight)
Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II Skin
Graft Carriers
Health Canada
41577
Type II
2008/06/05
N/A
N/A
Health Canada
42114
Type II
2008/06/05
2992 0968
SN080633
AquaJoy battery chargers (Serial no. 0638)
MHRA
2007/011/026/401/005
FSCA
2008/06/06
N/A
N/A
SN080634
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
2876 7525
MHRA
2008/005/021/061/004
FSCA
2008/06/10
2992 0968
MHRA
2008/003/022/601/200
FSCA
2008/06/11
N/A
N/A
SN080641
GE Healthcare OEC Uroview 2800, 9800 Plus, MiniView 6800,
Flexiview 8800 Mobile C-Arm
MHRA
2008/003/031/061/005
FSCA
2008/06/11
GE Healthcare
2609 9233
SN080642
Siemens Mevatron and Oncor Control Console Versions V6.5.079,
V7.2.079 and V9.1.50
MHRA
2008/005/001/291/016
FSCA
2008/06/11
Siemens Ltd.
2810 7533
SN080643
Boston Scientific NAMIC MorseR Angiographic Manifold
Boston Scientific
Hong Kong Ltd
N/A
2008/06/12
2960 7136
SN080644
CalMed Pericardial Sump
FDA
Z-1175-2008 to Z-1177
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
2008/06/16
Accuray Asia Ltd
2247 8628
MHRA
2008/005/022/061/020
FSCA
2008/06/17
2575 8668
MHRA
2008/005/021/601/353
FSCA
2008/06/17
N/A
N/A
SN080639
SN080640
Zimmer NexGen Complete Knee Solution Articular Surface Insertion
Instrument
CMS XiO/Focal
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
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
SN080653
GE Healthcare Centricity PASCS Software versions: 3.0.0X, 3.0.1X,
3.0.2.X AND 3.0.3X
MHRA
2008/006/003/291/010
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080654
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, LNET05, L-NETC05
MHRA
2008/005/002/601/317
FSCA
2008/06/17
GE Healthcare
2609 9233
SN080659
Hansen Medical Artisan Control Catheter
MHRA
2008/005/028/061/019
FSCA
2008/06/17
N/A
N/A
SN080660
Johnson and Johnson Ethicon Endo-Surgery ENDOPATH ETS
35mm
MHRA
2008/005/009/121/011
FSCA
2008/06/17
Kong
2738 2818
13
SN080661
Philips X-Ray Systems with Monitor Ceiling Suspension
MHRA
2008/006/003/291/004
FSCA
2008/06/17
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
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
2277 6125
N/A
2008/06/19
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
2789 3300
SN080676
Boston Scientific Platinum PlusT Coronary Guidewire
N/A
2008/06/23
2960 7136
SN080677
Boston Scientific Safety PEG Kits
SN080678
Conmed DetachaTip Surgical Instruments
SN080666
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
MHRA
N/A
2008/06/23
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
SN080680
GE LOGIQ3 Expert ultrasound scanner with software versions 4.0.5,
4.1.1 and 4.1.2
Huntleigh Healthcare Arjo Malibu
MHRA
2007/009/007/301/001
FSCA
2008/06/23
Arjo Far East Ltd
2508 9553
SN080681
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
St Jude Medical Livewire TC Ablation Catheter
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
MHRA
2008/001/022/401/007
FSCA
2008/06/23
N/A
N/A
SN080679
SN080688
ThermoFisher Scientific PB0124A Columbia agar with chocolated
horse blood
Unomedical OP tubing (Lot No 182281)
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
2008/06/25
Coloplast (Hong Kong) Ltd
3628 7428
SN080692
Boston Scientific implantables devices, ICD and CRT-D
N/A
2008/06/26
2960 7136
SN080687
Coloplast (Hong
Kong) Ltd
Boston Scientific
Hong Kong Ltd
14
SN080693
Computerized Medical Systems XIO Radiation Treatment Planning
System
SN080694
Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE
RADIOLOGY V.3.5, IVAULT V.3.5)
Health Canada
42273
SN080695
Gambro cartridge blood set (Model 003410-510, 003410-710,
0141080XXXC)
Health Canada
SN080696
Maquet HL 30 Perfusion System
SN080697
Stryker Infravision Urethral Kit (Model 0220-180-516)
SN080698
2008/06/27
N/A
N/A
Type II
2008/06/27
2821 5480
42069
Type II
2008/06/27
2839 7010
Health Canada
41066
Type II
2008/06/27
2393 9511
Health Canada
42415
Type II
2008/06/27
Stryker China Ltd
2518 6915
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
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
Health Canada
42336
15
Type II
Monthly Summary of Medical Device Safety Alerts -May 2008
MDCO Ref.
No.
Source of
Information*
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
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
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
Action
2008/05/05
Baush and Lomb
2213 3371
Accuray Asia Ltd
N/A
Action
2008/05/05
Accuray Asia Ltd
2247 8628
SN080507 Phonak Rubber Dome BTE hearing instruments
MHRA
2007/011/020/061/002
FSCA
2008/05/07
N/A
N/A
Edwards Lifesciences Aquarius Regular Haemofiltration Machine
SN080508
with software version 4.01.11
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
2919 1300
SN080517 Medtronic Bravo PH Capsule With Delivery System
Health Canada
39316
Type II
2008/05/08
2919 1300
SN080518 Varian Medical Clinac High and Low Engery
Health Canada
41305
Type II
2008/05/08
N/A
SN080519 Cardinal Health Custom Sterile Total Joint Pack
Health Canada
41543
Type II
2008/05/08
N/A
N/A
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)
2519 9182
SN080505 Bausch & Lomb XP MicroKeratome motors
SN080506
SN080509
Accuray CyberKnife Robotic Radiosurgery System MultiPlan
Treatment Planning Sofetware (Catalog No 022986)
Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306554)
16
SN080521 National Biological Houva III
Health Canada
41407
Type II
2008/05/08
N/A
N/A
SN080522 Biosense Webster Lasso Variable Deflectable CIR Map Catheter
Health Canada
41774
Type II
2008/05/08
N/A
N/A
SN080523 Levitronix CentriMag Systems
Health Canada
41786
Type II
2008/05/08
N/A
N/A
Medtronic International
Ltd
N/A
Action
2008/05/08
2919 1300
Health Canada
41574
Type II
2008/05/08
Biomerieux (Hong Kong)
2356 7033
Health Canada
41659
Type II
2008/05/08
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
2789 3300
MHRA
2008/004/009/301/001
FSCA
2008/05/08
N/A
N/A
Convatec
N/A
Action
2008/05/09
Convatec
Con
Division of E.R. Squibb
Squibb &
vatec, A Division
Sons, L.L.C. (Hong Kong)
2519 9182
MHRA
2008/004/008/291/002
FSCA
2008/05/09
2992 0968
2008/05/14
2960 7128
2008/05/14
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)
SN080533
Zimmer Hemovac, HAS, Sergivac, Infection Control and MiniHemovac Systems
SN080534 Boston Scientific iReview SoftwareVer1.0
SN080535 Boston Scientific OMG Connector-A
Boston Scientific
Hong Kong Ltd
Boston Scientific
Hong Kong Ltd
Action
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
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
MHRA
2008/004/023/291/003
FSCA
2008/05/14
N/A
N/A
P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable)
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
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
2332 4455
SN080545 Tyco Healthcare Monoject Prefill
FDA
Z-1594-2008 to Z-1602-2008
Class II
2008/05/15
COVIDIEN
3157 7244
17
SN080546
Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation
Device
SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes
SN080548
Baxter HomeChoice Automated Peritoneal Dialysis System
(Software v.10.210)
SN080549 Boston Scientific iLab UltraSound Imaging System
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/05/16
2960 7128
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/05/16
2960 7128
N/A
Action
2008/05/16
2807 8500
MHRA
2008/004/024/061/011
FSCA
2008/05/19
2960 7128
2738 6000
SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps
MHRA
2008/004/021/061/008
FSCA
2008/05/19
Kong
SN080551 Respironics Humidifier Chambers
MHRA
2008/003/028/401/001
FSCA
2008/05/19
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
ith
PCA
Smit
hs Medical Graseby Omnifuse and Omnifuse P
CA Syringe
SN080557
Pumps
MHRA
2008/003/006/061/008
FSCA
2008/05/21
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
2806 4021
SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor
MHRA
2008/004/024/061/014
FSCA
2008/05/22
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
MHRA
2008/004/023/061/009
FSCA
2008/05/22
2277 6611
SN080562
Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 65414-805)
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
SN080567 B Braun Dialog+ Machines with DF Option
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
N/A
18
MHRA
2008/004/028/601/297
FSCA
2008/05/23
Company
Company
Company
Beckman Coulter
SN080575 Siemens ACUSON Antares, Ultrasound System
Health Canada
41792
Type II
2008/05/23
Siemens Ltd.
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
2877 3077
2008/05/23
Kong
2738 6000
SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR)
MHRA
2008/004/030/601/310
FSCA
2008/05/23
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
Beckman Coulter Access and Access 2 Immunoassay Systems,
SN080574
SYNCHRON LXi 725 System and UniCel DxC 600i System
SN080578 Draeger Medical Oxylog 3000
2810 7533
2810 7533
2810 7533
2240 6260
2810 7533
41844
Type II
Johnson & Johnson
Medical Hong Kong
N/A
Action
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/05/26
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
19
cal Device Safety Alerts -April 2008
and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
No.
Source of
Information*
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
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
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
Z-1353-2008
Z-1360-2008
Class II
2008/04/03
N/A
N/A
AMO Asia Limited
N/A
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
SN080417 Medivance Instruments Velopex Extra X
MHRA
2008/001/003/061/013
FSCA
2008/04/11
N/A
N/A
Thermogenesis Disposable Processing Set for the AXP System 8SN080418
5101
MHRA
2008/003/012/061/002
FSCA
2008/04/11
N/A
N/A
SN080419 Elekta Stereotactic Body Frame CT and MRI indicators
MHRA
2008/002/029/601/139
FSCA
2008/04/14
N/A
N/A
SN080411 Hospira Butterfly winged needle infusion set
SN080416
20
SN080420
Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part
No. 80111-01)
MHRA
2008/003/025/061/013
FSCA
2008/04/14
2806 4021
SN080421
Arcomedical 3101-TJ (FSB123) Blood Set with Lower Y site
(Batches C8446)
MHRA
2008/003/013/601/181
FSCA
2008/04/14
N/A
N/A
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/15
2960 7128
2008/04/16
2960 7128
2008/04/16
2960 7128
2008/04/16
2960 7128
SN080422 Boston Scientific RX Plastic Biliary Stents
Boston Scientific Precision Implantable Pluse Generator (UPN
SN080423
M365SC11100)
SN080424 Boston Scientific Mach 1 Guide Catheter
SN080425 Boston Scientific Single-Use Rotatable Snares
SN080426 Boston Scientific SteeroCath-Dx and SteeroCath-T Catheters
SN080427
Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent
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
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
Action
Action
Action
Action
Action
Action
Action
N/A
N/A
N/A
N/A
N/A
N/A
N/A
FDA
Z-1448-2008 to Z-1458
Z-1448-2008
Z-1458-2008
-2008
Class II
2008/04/17
2992 0968
SN080431
Medtronic AneuRx AAAdvantage Endovascular Stent Graft with the
Xcelerant Delivery System
FDA
Z-0689-2008
Class II
2008/04/17
2919 1300
SN080432
Myelotec Steerable Video Guided Catheter (Product Code 2000
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
SN080436 Abbott Vascular Xact Rapid Exchange Carotid Stent System
MHRA
2008/003/031/291/008
FSCA
2008/04/17
2806 4021
PROACT Silicone Disposable Armoured LMA SAD-LA6320, SADSN080437
LA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350
MHRA
2007/012/021/401/014
FSCA
2008/04/18
N/A
N/A
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
SN080438
Siemens Medical IMMULITE 2000 CEA kit L2KCE2,6 lot 232 and
IMMULITE 2500 CEA kit L5KCE2,6 lot 111
21
SN080444
Biohorizons Single-Stage Implant System 122-800 Kit (Model 122800)
Health Canada
41374
Type II
2008/04/22
9656 7000
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
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
p
p torch (Model
(
pen
no. W2137))
SN080454 Merlin Medical Disposable
MHRA
MDA/2008/028
MDA
2008/04/23
N/A
N/A
GE Medical Systems
Hong Kong Ltd.
N/A
Action
2008/04/24
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
2789 3300
SN080447
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
C
SN080449 Meridian Bioscience Immunocard Toxins A & B
SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes)
22
Monthly Summary of Medical Device Safety Alerts -March 2008
MDCO Ref.
No.
Source of
Information*
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
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
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
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
23
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
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
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
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
2992 0968
SN080333
Zimmer Hemovac Infection Control Kits
Health Canada
40972
Type II
2008/03/19
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
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
2960 7128
SN080339
Draeger Medical Fabius GS (Model# 8604700)
Health Canada
40720
Type II
2008/03/19
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
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
24
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
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
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
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
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
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
SN080363
Medtronic LIFEPAK 1000
Medtronic
International Ltd
N/A
Action
2008/03/26
2919 1300
SN080364
Cryocath FlexCath Steerable Sheath(Ref 3FC12)
Cryocath
Technologies Inc.
N/A
Action
2008/03/26
Cryocath Technologies Inc.
N/A
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
25
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
2877 3077
SN080368
Smith & Nephew CALAXO Bioabsorbable Interference Screw
FDA
Z-0593-2008 to Z-061612008
Class II
2008/03/27
2648 7700
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
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
2960 7128
Action
Action
SN080375
Boston Scientific COGNIS CRT-D device
SN080376
Osypka Medical
Medical External Dual Chamber
Chamber Pluse
Pluse Generator
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
2332 4455
SN080380
Philips Brilliance CT Systems
Health Canada
39694
Type II
2008/03/31
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
2876 7525
SN080382
Steris Tenzor Carbon Fiber Orthopedic Traction
Health Canada
41089
Type II
2008/03/31
N/A
SN080383
Steris C1160 Tray used with Steris System 1
Health Canada
41078
Type II
2008/03/31
N/A
SN080384
Steris Amsco Remanufactured Prevacuum Sterilizers
Health Canada
41256
Type II
2008/03/31
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
N/A
26
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
27
Monthly Summary of Medical Device Safety Alerts -February 2008
MDCO Ref.
No.
Source of
Information*
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
SA080205
VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7100)
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
Z-0258-2008
Class II
01-Feb-08
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
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
Kong
2738 2818
SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01)
FDA
Z-0551-2008
Class II
01-Feb-08
2806 4021
SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20)
FDA
Z-0127-2008
Class II
01-Feb-08
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
2876 7525
MHRA
2008/001/024/601/003
FSCA
04-Feb-08
2806 4021
MHRA
2008/001/014/291/020
FSCA
04-Feb-08
Stryker China Ltd
2518 6988
MHRA
2008/001/021/601/002
FSCA
04-Feb-08
Siemens Ltd.
2810 7533
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)
28
SA080219
Roche COBAS AmpliPrep/ COBAS Taqman & High Pure
System/COBAS Taqman 48
SA080220 Corin Cormet Head Trial Size 4/44
SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups
MHRA
2007/011/019/291/011
MHRA
2008/001/023/291/002
FSCA
04-Feb-08
Limited
2485 7510
FSCA
04-Feb-08
N/A
N/A
04-Feb-08
Stryker China Ltd
2518 6988
06-Feb-08
2268 9258
Action
Action
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
FDA
Z-0527-2008 to Z-0528-2008
Class II
11-Feb-08
2807 8555
FDA
Z-0461-2008 to Z-0462-2008
Class II
11-Feb-08
2876 7525
SA080227 Philips Page Writer Touch Cardiograph (Model # 860284)
FDA
Z-0124-2008
Class II
11-Feb-08
2876 7525
SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ
FDA
Z-0690-2008 to Z-0692-2008
Z-0690-2008
Z-0692-2008
Class II
11-Feb-08
11-Feb-08
2783 1838
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
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
SA080226
SA080229
Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6, 10
and 16 slice PET/CT Systems
Blackstone Hallmark Anterior Cervical Plate System (REF#623140)
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
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
FDA
Z-0135-2008
Class II
18-Feb-08
FDA
Z-0948-2008 to Z-0949-2008
Class II
18-Feb-08
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)
29
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2)
A.R. Burkhill & Sons (Hong Kong) Ltd.
2541 1041
886-22183-6130
SA080242 Medtronic Cardioblate Gemini-s model 49260
FDA
Z-0727-2008
Class II
18-Feb-08
886-22183-6130
SA080243 Siemens Dade Behring BEP III System
MHRA
2008/002/005/061/014
FSCA
20-Feb-08
Siemens Ltd.
2810 7533
SA080244 Care & Independence Systems InChair Sling
MHRA
2007/004/030/261/002
FSCA
20-Feb-08
N/A
N/A
MHRA
2008/002/011/061/008
FSCA
21-Feb-08
2783 1838
MHRA
2008/002/006/601/033
FSCA
21-Feb-08
2783 1838
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
SA080247
Abbott Comfort T-handle Hudson Connector with Impactor Cap
(Part # 1006-1)
FDA
Z-0880-2008
Class II
22-Feb-08
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
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
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
q
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
Z-0871-2008
Z-0875-2008
Class II
22-Feb-08
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
2485 7510
SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX
MHRA
2008/002/006/291/001
FSCA
22-Feb-08
Limited
SA080256 Philips General X-Ray System
MHRA
2008/002/012/061/007
FSCA
22-Feb-08
2876 7525
SA080257 Philips X-Ray System Types Omni Diagnost Eleva
MHRA
2008/002/013/061/004
FSCA
22-Feb-08
2876 7525
SA080258
Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating
patch - (i) Back; (ii) Arm, Neck, and Leg
FDA
N/A
Press Release
26-Feb-08
N/A
N/A
Philips Easy Diagnost Eleva family, Easy Diagnost Classic family
SA080259
and Diagnost 76 plus family
MHRA
2008/002/012/061/008
FSCA
27-Feb-08
2876 7525
SA080260 Medtronic Internal Defrillation Handles and Electrodes
MHRA
2008/002/015/061/001
FSCA
27-Feb-08
886-22183-6130
MHRA
2008/002/014/601/063
FSCA
27-Feb-08
N/A
N/A
Bausch and Lomb
N/A
Action
27-Feb-08
Baush and Lomb
2213 3371
FDA
N/A
Press Release
29-Feb-08
2807 8555
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
SA080261
Baxa Corporation EM4200 Exacta-Mix Compounder Operating
Software V1.05, 1.06 & 1.06.1
SA080262 Bausch and Lomb Stellaris Vision Enhancement System
SA080263
Baxter Heparin Sodium Injection multi-dose, single dose vials and
HEP-LOCK heparine flush products (lots: ALL)
Siemens Primus Linear Accelerator System and Mevatron Linear
SA080264
Accelerator Systems
Siemens Syngo Imaging System with VB30A version of software
(Model No. 10014063)
SA080266 Kodak DirectView Model DR 3000 System, Stationary X-Ray
System
SA080265
30
SA080267
Hill-Rom Avantguard 1200 and 1400 with manually operated lockout function
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
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
2876 7525
SA080273 Philips EasyVision RAD
MHRA
2008/002/020/061/007
FSCA
29-Feb-08
2876 7525
SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B)
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)
SA080271
Nova EZ CHEM Creatinine Meter, Control Solution and Linearity
Solution
SA080274
Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No
1320-0231)
MHRA
2008/002/006/061/001
FSCA
29-Feb-08
Stryker China Ltd
2518 6988
SA080275
Philips Digital Diagnost family, Bucky Diagnost family, Easy
Diagnost family, Thoravision
MHRA
2008/002/019/061/020
FSCA
29-Feb-08
2876 7525
29-Feb-08
Kong
2738 2818
SA080276 Depuy polyethylene knee bearings
MHRA
2007/010/031/061/010
31
FSCA
Monthly Summary of Medical Device Safety Alerts -January 2008
MDCO Ref.
No.
Source of
Information*
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
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
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
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
Mask Green
g
g Shield Surgical
g
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
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
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
SA080119
Fresenius Medical Care multiFiltrate acute dialysis system
MHRA
2007/012/017/051/003
FSCA
2008/01/09
Fresenius Medical Care Asia Pacific
Ltd.
N/A
BD
N/A
Action
2008/01/09
BD
2575 8668
FDA
Z-0457-2008
Class II
2008/01/11
2356 7033
SA080120
SA080121
BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Sterile Convenience
Paks
bioMerieux, BacT/ALERT FA Culture Bottles (Lot no 1017685,
101793 and 1017788)
32
SA080122
SA080123
Abbott CELL-DYN Sapphire Hemoglobin Reagent Analyzer
Syringes (List no 08H49-02)
Siemens IMMULITE/IMMULITE 1000, IMMULITE 2000 and
IMMULITE 2500 Operators
FDA
Z-0301-2008
Class II
2008/01/11
2806 4201
MHRA
2008/001/004/601/001
FSCA
2008/01/14
Siemens Ltd.
2810 7533
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.
SA080125
Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ;
Lot # 20060605)
MHRA
2007/012/020/061/001
FSCA
2008/01/14
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
Action
2008/01/16
2960 7128
SA080133
Boston Scientific Slimline 200 Micron Delivery System
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/01/16
2960 7128
SA080134
Boston Scientific Galaxy 2 and ClearView Systems
Boston Scientific
Hong Kong Ltd
N/A
Action
2008/01/16
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
Action
2008/01/16
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
Action
2008/01/16
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
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: SSA790A with version 1.1 software)
FDA
Z-0305-2008
Class II
2008/01/17
N/A
N/A
2645 8703
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
33
SA080147
Baxter Healthcare Home Choice Automated PD System and Home
Choice Pro Automated PD System
Health Canada
39272
Type II
2008/01/18
2807 8555
SA080148
Baxter Healthcare Infusor 2mL/HR
Health Canada
39388
Type II
2008/01/18
2807 8555
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
2876 7525
SA080153
Philips Medical BV Endura and BV Pulsera (Model# MMC 2011,
MMC 2011)
Health Canada
39582
Type II
2008/01/18
2876 7525
SA080154
Varian RPM Respiratory Gating System
Health Canada
39358
Type II
2008/01/18
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
Limited
2485 7510
SA080156
Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133,
133X)
Health Canada
39423
Type II
2008/01/18
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
SA080161
St. Jude Medical Epic, Atlas and Convert Family of ICDs
St. Jude Medical
N/A
Action
2008/01/18
St. Jude Medical
N/A
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
2876 7525
MHRA
2007/012/024/601/003
FSCA
2008/01/21
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
2008/001/017/291/013
FSCA
2008/01/24
N/A
N/A
SA080170
Medtronic Synchromed EL, Synchromed II and IsoMed drug
infusion pumps
Medtronic
International Ltd
N/A
Action
2008/01/24
2891 4456
SA080171
ev3 IntraStent Unmounted Balloon Expandable Stents
MHRA
2008/001/011/291/003
FSCA
2008/01/28
Conmed Limited
2854 4413
SA080172
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
34
SA080174
Dixons Tudor Edwards Double Rib
MHRA
2008/001/017/601/001
FSCA
2008/01/28
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
SA080177
Stryker V40 Femoral Heads
MHRA
2008/001/016/121/001
FSCA
2008/01/30
Stryker China Ltd
2518 6988
SA080178
Johnson and Johnson STERRAD Sterilizer System (50, 100S, 200
and NX Sterilizers)
MHRA
2007/012/004/061/009
FSCA
2008/01/30
Kong
2738 2818
SA080179
Medtronic Model 8870 N'Vision Clinican Programmer Software
Application Card
MHRA
2008/001/003/291/014
FSCA
2008/01/30
2891 4456
SA080180
Biosite Triage Micro C. Difficile Panel (Catalog no 96000)
MHRA
2008/001/017/291/003
FSCA
2008/01/30
N/A
N/A
SA080181
AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and Normal
Saline IV Flush Syringes (All Lots and All Sizes)
FDA
N/A
Class I/Press Release
2008/01/31
N/A
N/A
35
N/A
Monthly Summary of Medical Device Safety Alerts -December 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Medtronic
International, Ltd.
N/A
Action
2007/12/03
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
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
SA071204
ZOLL LifeVest WCD3000 Battery Pack
MHRA
2007/011/026/061/018
FSCA
2007/12/04
N/A
N/A
SA071205
Draeger Medical Anaesthetic Gas Scaverging System (AGSS)
receiver
Procare Privac set (Product code 24760)
MHRA
MDA/2007/090
MDA
2007/12/05
2877 3077
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
2807 8555
SA071209
Ohio Willow Wood Alpha
p Original
g
Locking
g Liners (A
( LL-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
SA071206
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
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
2866 0811
SA071218
Terumo Ultrasonic Air Sensor (Model: 5773, 5785, 5791)
Health Canada
39116
Type II
2007/12/10
2866 0811
SA071219
Philips M3170 Intellivue Patient Link (Model: M3170, LOT: S/A
4721A01711)
Health Canada
38975
Type II
2007/12/10
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
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
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)
SA071222
SA071223
36
2738 2894
SA071226
Toshiba-Interventional Angiography System, Infinix i (Model DFP8000D)
FDA
Z-0293-2008
Class II
2007/12/10
2384 0688
SA071227
Medtronic 0-arm Imaging System (Product Code B1-700-00027)
FDA
Z-0294-2008
Class II
2007/12/10
2919 1362
SA071228
Zimmer Durom Hip Resurfacing Systems, Femoral Component 54
Code T and 46 Code L (Cat no. 01.00211.154 and 01.00211.146)
FDA
Z-0275-2008 to Z-0276-2008
Class II
2007/12/10
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
SA071229
SA071230
SA071231
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)
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
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
Limited
2485 7510
SA071236
SA071237
Henry
e y Sc
Schein
e EasyCam
asyCa Eurolite,
u o te, Eurolite
u o te II a
and
d Eu
urodoc
odoc Intra-oral
taoa
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
2332 4455
N/A
SA071241
Straumann Palatal Implant (Article No. 042.335S and 042.336S)
SA071242
Frenius Kabi Applix Smart pump (all models)
SA071243
SA071244
SA071245
SA071246
SA071247
SA071248
SA071249
SA071250
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)
B. Braun Excia Cemented Hip Stems (Size 9mm to 18mm)
FDA
Z-0277-2008 to Z-0278-2008
Class II
2007/12/14
N/A
MHRA
MDA/2007/098
MDA
2007/12/18
Ltd
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
FDA
Z-0436-2008 to Z-0445-2008
Class II
2007/12/20
B. Braun Medical (Hong Kong) Ltd.
2277 6125
37
SA071251
Abbott ARCHITECT c8000 Processing Module (List no 106-01)
and ARCHITECT c16000 Processing Module (List no 3L77-01)
Roche Diagnostics LightCycler Capillaries (100uL) (Catalog #
03337090001, 04391039001, 03603946001, 03531414201)
ConMed Accessory Electrode, Universal Electrodes and Ultra
Clean Accessory Electrode
FDA
Z-0146-208 to Z-0147-2008
Class II
2007/12/20
2806 4021
FDA
Z-0459-2008
Class II
2007/12/20
Limited
2485 7510
FDA
Z-0452-2008
Class II
2007/12/20
N/A
N/A
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
2992 0968
FDA
Z-0363-2008
Class II
2007/12/21
N/A
N/A
SA071252
SA071253
SA071254
SA071260
SA071261
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)
SA071262
ACIST Multi-Use Syringe Kit (Model A2000; SKU# 014612,
Catalog#800061-003)
g
)
FDA
Z-0359-2008
Class II
2007/12/21
N/A
N/A
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
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
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
Action
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
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
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
2814 0481
SA071276
Beckman Coulter Cytomics FC 500 Flow Cytometer
Health Canada
37157
Type II
2007/12/31
2814 0481
SA071277
Beckman Coulter Sychron CX Systems salicylate reagent
Health Canada
39284
Type II
2007/12/31
2814 0481
38
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
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
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
SA071281
Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 50800-036 and 508-00-040)
FDA
Z-0184-2008 to Z-0185-2008
Class II
2007/12/31
N/A
N/A
SA071282
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)
FDA
Z-0286-2008 to Z-0287-2008
Class II
2007/12/31
N/A
N/A
SA071283
OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs
and Screw Systems, Distal Screw and Distal Peg
FDA
Z-0136-2008
Class II
2007/12/31
N/A
N/A
SA071284
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
39
Month
*Note: FDA
F d d
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA071101
Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup
FDA
Z-0017-2008 to Z-0033-2008
Class II
2007/11/01
Smith & Nephew Ltd.
2648 7700
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
2876 7525
SA071104
BD Microkeratome K3000 and K4000 (Cat No. 378660)
FDA
Z-0062-2008
Class II
2007/11/01
BD
2575 8668
SA071105
Steris QFC1728 and QFC1729 Quick Connects
Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back
acetabular shell
FDA
Z-0101-2008
Class II
2007/11/01
2518 6988
SA071106
FDA
Z-0072-2008 to Z-0073-2008
Class II
2007/11/01
Stryker China Ltd
SA071107
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
2240 6260
SA071111
Boston Scientific RepliformR Tissue Regenration Matrix
Boston Scientific(HK)
Ltd
N/A
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
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
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
2866 0811
SA071119
Toshiba Aplio XG (SSA-790A)
Health Canada
38432
Type II
2007/11/12
2384 0688
SA071120
Baxter Healthcare Duoject EASY-Prep System
Health Canada
38628
Type II
2007/11/12
2807 8517
SA071121
Abbott Aeroset System-Creatine Kinase Assay (Model 7D63-30)
Health Canada
38476
Type II
2007/11/12
2806 4021
SA071122
Abbott Accelerator APS System Input/Output Module (IOM) (Model:
7L01-01)
Health Canada
38529
Type II
2007/11/12
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
40
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
2240 6260
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
2919 1362
SA071129
Philips Brilliance CT Big Bore (Model No. 728243)
FDA
Z-0121-2008
Class II
2007/11/19
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
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
2783 1838
SA071133
GE Sunisa Flexi-DT S0014115 Digital Table Flexi-DT
FDA
Z-0075-2008
Class II
2007/11/19
2783 1838
SA071134
Abbott AxSYM Digoxin III Reagent Pack (List 6L07-20)
FDA
Z-0064-2008
Class II
2007/11/19
2806 4021
SA071135
Smiths Medical Portex Perfit Percutaneous Tracheostomy Tube
Replacement Kit (Sterile Ref: 536090)
FDA
Z-0100-2008
Class II
2007/11/19
2648 7700
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
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
MHRA
2007/006/005/401/014
FSCA
2007/11/20
N/A
N/A
SA071142
APC Medical Bedside Temporary Cardiac Pacemaker (Model
4170)
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
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
2376 1805
SA071145
Pride Mobility Quantum 6000, 6000Z, 600, R-4000 and 1420, Pride
LX Power wheelchair
MHRA
2007/008/008/301/001
FSCA
2007/11/22
N/A
N/A
SA071146
DiaSorin LIAISON Toxo IgM (Cat no 310710, lot no: 035052,
035052/1, 035052/2)
MHRA
SA071141
2007/009/027/601/003
FSCA
2007/11/22
N/A
N/A
N/A
Action
2007/11/26
2960 7128
SA071147
Boston Scientific LeVeen SuperSlim Needle Electrodes
Ltd
SA071148
Boston Scientific Impulse Angiographic Catheter
Ltd
N/A
Action
2007/11/26
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
2789 3300
SA071152
Kavo Estertica E80 Treatment Unit
MHRA
2007/011/013/061/011
FSCA
2007/11/26
N/A
N/A
41
SA071153
GE AW 4.2, AW Volumeshare and AW Volumeshare 2
Health Canada
38214
Type I
2007/11/27
BD BBL Fluid Thioglycollate Medium and BBL Trypticase Soy Broth
(Model no 299108 and 299107)
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
38700
Type II
2007/11/27
BD
2575 8668
Health Canada
Health Canada
36689
38822
Type II
Type II
2007/11/27
2007/11/27
2783 1838
2806 4021
Health Canada
32105
Type II
2007/11/27
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
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
SA071154
SA071155
SA071156
SA071157
SA071162
Hill-Rom Versacare Hospital Beds (model P3200 and P3201)
2783 1838
SA071163
GE OEC Insta Trak 3500 Plus with the Cranial Application
FDA
Z-0183-2007
Class II
2007/11/27
2783 1838
SA071164
GE OEC Insta Trak 3500 Plus Fluoro Trak and Fluoro CAT Spinal
Applications
FDA
Z-0181-2007
Class II
2007/11/27
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
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
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
2277 6162
FDA
Z-0255-2008
Class II
2007/11/29
2332 4455
FDA
Z-0263-2008
Class II
2007/11/29
2807 8517
FDA
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
Z-0289-2008
Class II
2007/11/29
N/A
N/A
Ltd
N/A
Action
2007/11/30
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
42
Monthly Summary of Medical Device Safety Alerts - October 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Ltd
N/A
Action
2007/10/02
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
MHRA
2005/011/016/301/004
FSCA
2007/10/03
N/A
N/A
SA071005
Varian Acuity radiation therapy simulation systems
Varian Medical
CP-2007-001
Action
2007/10/03
2724 2836
SA071006
Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073)
Pharmacy Compounding System
FDA
Z-1238-2007
Class I
2007/10/04
Jaspo Limited
2713 0007
SA071007
GE Healthcare OEC9900, OEC9800 and OEC8800
SA071008
Philips Gemini 16, Gemini GXL, Precedence and Brilliance
SA071009
SA071010
SA071011
SA071012
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)
MHRA
2007/008/029/291/017
FSCA
2007/10/04
2783 1838
FDA
Z-0013-2007 to Z-0014-2007
Class II
2007/10/04
2876 7525
FDA
Z-0907-2007 to Z-0912-2007
Class II
2007/10/04
2876 7525
FDA
Z-1212-2007
Class II
2007/10/04
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
SA071013
GE Innova 2100-IQ Digital Fluoroscopic Imaging System
FDA
Z-1088-2007
Class II
2007/10/04
2783 1838
SA071014
Cerner Millennium RadNet Auto Launch Study and Auto Launch
Report Software functionalilites
FDA
Z-1243-2007
Class II
2007/10/04
N/A
N/A
SA071015
Davol Salute Fixation Reusable Handle, Fixation Reusable Shaft,
Laparoscopic Sterile Implant Cartridge and Short Sterile Implant
Cartridge
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
NxStage Cartridge Express (CAR-170)
FDA
Z-1228-2007
Class II
2007/10/04
N/A
N/A
SA071021
Summit LX125 Swivel Collimator (Model D800), LX125V Swivel
Collimator (Model E600) and PCS125 Swivel Collimator (Model
FDA
Z-1216-2007 to Z-1218-2007
Class II
2007/10/04
N/A
N/A
SA071022
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
2783 1838
SA071027
Otto Bock Standard Kimba Spring (Ref TS8423)
MHRA
2007/004/010/301/001
FSCA
2007/10/08
Otto Bock Asia Pacific Limited
2598 9772
SA071028
Boston Scientific Transend EX Standard 0.014" Guidewire
Ltd
N/A
Action
2007/10/10
2960 7128
43
SA071029
SA071030
Boston Scientific Advanced Bionics PrecisionR Implantable Pulse Boston Scientific(HK)
Generator -UPNM365SC11100
Ltd
Varian RTP Exchange software (interface application that supports
Varian Medical
the electronic transfer of radiation treatment planning data)
N/A
2007/10/10
2960 7128
2007/10/10
2724 2836
SA071031
GE Disposable Multi Absorber Canister
FDA
Z-0006-2008
Class II
2007/10/11
2783 1838
SA071032
CVI OZ Palm Injector (Ref: OZ 1035)
FDA
Z-0008-2008
Class II
2007/10/11
Suburfarm Investment and Trading Co.
Ltd.
2780 9421
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
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
SA071036
Dale 240 Blue Tracheostomy Tube Holders and Dale 242 Blue
Tracheostomy Tube Holders for Neonates to Infants
MHRA
2007/009/028/291/005
FSCA
2007/10/11
N/A
N/A
SA071037
Varian Real-time Position Management System (RPM) version 1.7
MHRA
2007/010/002/061/003
FSCA
2007/10/12
2724 2836
SA071038
MAQUET ELS-Cannulae
Stryker Locking Screw, Fully Threaded 5 x 70 mm (Cat. no. 18965070S, Lot/Batch no. K871252)
Karl Storz Morcellator Cutter 12mm
MHRA
2007/010/003/291/010
FSCA
2007/10/12
Maquet Hong Kong Limited
2393 9511
MHRA
2007/009/025/291/002
FSCA
2007/10/12
Stryker China Ltd
2518 6988
SA071039
SA071040
CP-2007-093
Action
Action
MHRA
2007/010/004/061/011
FSCA
2007/10/12
N/A
N/A
SA071041
Siemens Mobile Magnetom Harmony, Symphony and Sonata
Systems
y
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
2007/010/004/291/001
FSCA
2007/10/15
2807 8555
SA071044
Medtronic Sprint Fidelis Defibrillation Leads
Medtronic
International, Ltd.
N/A
Action
2007/10/15
2919 1362
SA071045
Toshiba Nemio and Nemio XG Ultrasound systems
MHRA
2007/009/026/061/007
FSCA
2007/10/16
2384 0688
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
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
SA071051
SA071052
SA071055
Cyberonics VNS Therapy Software, Model 250
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
SA071056
MHRA
2007/009/027/601/002
FSCA
2007/10/16
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
Action
2007/10/17
N/A
N/A
MHRA
2007/008/001/601/004
FSCA
2007/10/18
2783 1838
MHRA
2007/008/014/061/005
FSCA
2007/10/18
N/A
N/A
MHRA
Ltd
2004/012/008/401/008
FSCA
Action
2007/10/18
N/A
N/A
2007/10/18
2960 7128
N/A
44
SA071060
Siemens Digital Linear Accelerators
Health Canada
37632
Type II
2007/10/22
Siemens Ltd.
2810 7533
SA071061
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
SA071064
Health Canada
37954
Type II
2007/10/22
2807 8555
Health Canada
37878
Type II
2007/10/22
2919 1362
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
Diagnostica STA Compact and STA Compact CT
SA071065
FDA
Z-0038-2008
Class II
2007/10/22
N/A
N/A
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)
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
SA071070
SA071071
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)
Z-0011-2008
Class II
2007/10/22
N/A
N/A
Medtronic
International, Ltd.
N/A
Action
2007/10/22
2919 1362
SA071072
Medtronic Model Model 7428 Kinetra and Model 7426 Soletra
implantable neurostimulators
SA071073
Abbott ARCHITECT cSystems
MHRA
2007/009/014/601/003
FSCA
2007/10/23
2806 4021
SA071074
y
Medtronic Nexframe Stereotactic System
MHRA
2007/010/011/061/005
FSCA
2007/10/23
Medtronic International,, Ltd.
2919 1362
SA071075
Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze
MHRA
2007/010/015/291/003
FSCA
2007/10/23
N/A
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
Siemens Clinitest hCG Cassette
MHRA
2007/010/018/061/010
FSCA
2007/10/25
Siemens Ltd.
2810 7533
SA071079
Smiths Medical EMS Ventilator circuits (Product code W196-002)
MHRA
MDA/2007/080
MDA
2007/10/25
N/A
SA071076
45
Monthly Summary of Medical Device Safety Alerts - September 2007
MDCO Ref.
No.
SA070901
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
SA070909
SA070910
SA070911
SA070912
SA070913
SA070914
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Ltd
N/A
Action
2007/09/03
2960 7128
MHRA
2007-008-024-061-012
FSCA
2007/09/05
N/A
JianXi FDA
N/A
N/A
2007/09/06
Jindun International (HK) Ltd
2851 0879
N/A
Action
2007/09/11
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
2806 4021
Smiths Medical Hyperflex (Model 75 FHXL80)
Health Canada
30529
Type II
2007/09/14
N/A
Smiths Medical Epidural Minipack and Epidural Syringe
Health Canada
29940
Type II
2007/09/14
N/A
Terumo Advanced Perfusion System 1 Base and Roller Pumps
Health Canada
36601
Type II
2007/09/14
2866 0811
Siemens Siregraph CF
Health Canada
36799
Type II
2007/09/14
Siemens Ltd.
2810 7533
Randox Laboratories Carbon Dioxide Reagent
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
Varian clinacs
BD FA Stretococcus Group A
SA070907 Abbott Blood Glucose Meter: Precision Xtra, Optium, ReliOn
Ultima, Rite Aid and Kroger
SA070908
Varian Medical
SA070905 BD Epicentre Microbiology Data Management
SA070906
Source of
Information*
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
Ltd
N/A
Action
2007/09/14
2960 7128
Boston Scientific Renegade HiFlo Microcatheter Kit
Ltd
N/A
Action
2007/09/14
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
SA070920 Molnlycke Biogel Skinsense Polyisoprene Surgical Gloves, NonLatex, Sterile (Size 8)
FDA
Z-1219-2007
Class II
2007/09/14
N/A
N/A
SA070921 Abbott CELL-DYN 3000, CELL-DYN 3500 and CELL-DYN 3700
Hematology Analyzer
FDA
Z-1198-2007 to Z-1200-2007
Class II
2007/09/14
2806 4021
SA070922 Sendx Medical (Radiometer Capenhagen ) ABL8O FLEX Software
Version 1.10 (Model no. 914863)
FDA
Z-1201-2007
Class II
2007/09/14
N/A
N/A
SA070917
SA070918
46
SA070923
SA070924
Abbott AxSYM System Digoxin III Reagent Pack
FDA
Z-1202-2007
Class II
2007/09/14
2806 4021
Abbott Multi-Link Vision RX Coronary Stent System
FDA
Z-1211-2007
Class II
2007/09/14
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
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
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
Philips MR Systems
MHRA
2007/001/023/081/009
FSCA
2007/09/17
2876 7525
Cascade Designs Varilite Back Support
MHRA
2006/010/011/261/001
FSCA
2007/09/17
N/A
N/A
MHRA
2007/006/005/061/010
FSCA
2007/09/17
2806 4021
MHRA
2007/008/014/601/004
FSCA
2007/09/17
2806 4021
2738 2818
SA070931
SA070932
SA070933 Abbott Precision Plus Blood Glucose Electrodes / Test Strips (Lot
no. 96425)
SA070934
SA070935
SA070936
SA070937
SA070938
SA070939
SA070940
Abbott Bilirubin Calibrator : 1E66-04
Depuy Engage Modular Revision Hip Implant Component
B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR")
Stericom STE 4021 Proctoscope
SA070943
SA070944
SA070945
SA070946
2007/007/025/061/016
FSCA
2007/09/17
FDA
N/A
Press Release
2007/09/18
2277 6162
MHRA
2007/007/030/061/008
FSCA
2007/09/18
N/A
N/A
Limited
Smiths & Nephew Healthcare (Hong
Kong)
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
2806 4021
Abbott Commander System Analyzer Class 4
Health Canada
37035
Type II
2007/09/19
2806 4021
Abbott Architect System - Lipase Assay
SA070941 Universal Hospital Supplies Sterile suction connecting tubing (ref
no. UN30026FFM)
SA070942
MHRA
J h
J h
M di l Hong
H
Johnson
& Johnson
Medical
Kong
Eschmann Electrosurgery bipolar unit (model TDB 60)
Welch Allyn AED20 Automatic External Defibrillators
2485 7510
2648 7700
Health Canada
35873
Type II
2007/09/19
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
2806 4021
SA070948 Medtronic Export XT Catheter
Health Canada
36691
Type II
2007/09/19
2919 1362
47
SA070949
Medtronic Paceart System Software - 2006 1st Edition
Health Canada
37173
Type II
2007/09/19
2919 1362
Health Canada
37033
Type II
2007/09/19
Siemens Ltd.
2810 7533
Health Canada
28486
Type II
2007/09/19
2648 7700
Health Canada
30639
Type II
2007/09/19
2648 7700
Smiths Medical Graseby MS26 Syringe Driver
Health Canada
24935
Type II
2007/09/19
2648 7700
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
2877 3077
Health Canada
37229
Type II
2007/09/19
2877 3077
Health Canada
35889
Type II
2007/09/19
Agfa Hong Kong Limited
2555 9421
Remel Wellcogen Bacterial Antigen Test
Health Canada
37147
Type II
2007/09/19
N/A
N/A
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
Z-1234-2007
Class II
2007/09/20
2876 7525
N/A
Action
2007/09/21
2960 7128
SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16
SA070951
Smiths Medical Portex Perfit Percutaneous Dilational
SA070952 Smiths Medical Portex Epidural and Spinal Needle Set
SA070953
SA070954
SA070956
Draeger Medical D-Vapor
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
SA070958
SA070959
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)
Ltd
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
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
2485 7510
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
MHRA
2007/007/030/051/009
FSCA
2007/09/21
Limited
MHRA
2007/009/010/291/015
FSCA
2007/09/21
2919 1362
N/A
N/A
SA070969 Metrax Primedic - DefiMonitor Models DX1, XD3, XD10, XD30,
XD100, XD300, XD110, XD330
SA070970 Arjo Otter lift and Arjo Pool Lift
MHRA
2007/008/028/061/009
FSCA
2007/09/24
MHRA
2007/006/014/601/002
FSCA
2007/09/24
Arjo Far East Ltd (Hong Kong)
2508 9553
SA070971 Smiths CADD Medication Cassette Reservoir
MHRA
2007/007/024/061/008
FSCA
2007/09/24
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
SA070975 Baxter Colleague CX Single Channel Volumetric Infusion Pumps,
product code 2M8161
FDA
Z-1224-2007
Class I
2007/09/27
N/A
N/A
48
SA070976
Abbott ARCHITECT Prolactin MasterCheck
SA070977 BD ReliOn 0.5cc 3g x 8mm Bilster Pak U-100 Syringe
SA070978
SA070979
Kimberly Clark BALLARD BAL CATH Kit
FDA
Z-1222-2007
FDA
Class II
2007/09/27
2806 4021
Z-1226-2007
Class II
2007/09/27
BD
2575 8668
Kimberly Clark Health
Care
N/A
Action
2007/09/27
N/A
N/A
Medtronic Intersept 3608 Sterile tubing (Lot 7626621)
FDA
Z-1227-2007
Class II
2007/09/27
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
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
49
Monthly Summary of Medical Device Safety Alerts - August 2007
MDCO Ref.
No.
SA070801
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
SA070806 GE Healthcare Extended Range Transmitter (Catalog Part
1004070 , 1003991)
SA070807
Tyco Kendall Curity Suprapubic Catheter Sets
SA070810
SA070811
SA070812
SA070813
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
Goodwin Healthcare
Ltd.
N/A
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
2876 7525
MHRA
2007/007/025/061/013
FSCA
2007/08/06
2783 1838
MHRA
2007/007/019/601/002
FSCA
2007/08/06
2783 1838
MHRA
2007/007/027/291/008,
2007/007/027/291/007
FSCA
2007/08/06
2783 1838
MHRA
2007/007/012/051/003
FSCA
2007/08/06
3157 7244
2802 2900
MHRA
2007/007/019/291/018
FSCA
2007/08/06
Teleflex Medical Hudson RCI Large Volume Nebuliser
MHRA
2007/006/012/401/015
FSCA
2007/08/06
Abbott ACCELERATOR APS System (7L01-01)
MHRA
2007/005/023/601/001
FSCA
2007/08/06
2806 4021
Trinity Biotech Captia Measles IgM ELISA Test Kit
MHRA
2007/007/009/061/003
FSCA
2007/08/06
N/A
N/A
Medtronic Intersept Filtered Cardiotomy Reservior (Model 1351)
FDA
Z-1110-2007
Class II
2007/08/06
2919 1362
Abbott Architect AUSAB Assay
FDA
Z-1096-2007 to Z-1098-2007
Class II
2007/08/06
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
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
MHRA
2007/007/024/291/007
FSCA
2007/08/07
2876 7525
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
Ltd
N/A
SA070808 Fresenius Medical Care HD Catheters
SA070809
Source of
Information*
Performance Health Products AXXIS, Comfort and V-Trak
SA070819 Philips Brilliance 40/64 CT Scanners
N/A
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
2919 1362
MHRA
2007/008/002/061/011
FSCA
2007/08/08
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
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
50
SA070825
SA070826
SA070827
Zimmer M/DN Intramedullary Fixation System
Health Canada
32026
Type II
2007/08/09
Cook Fixed Core Stainless Stell Wireguide
Health Canada
35942
Type II
2007/08/09
Cook Asia Ltd
2992 0968
(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
2960 7128
SA070829 Siemens ECAT
Health Canada
36463
Type II
2007/08/09
Siemens Ltd.
2810 7533
Health Canada
36560
Type II
2007/08/09
Siemens Ltd.
2810 7533
Health Canada
36426
Type II
2007/08/09
Siemens Ltd.
2810 7533
Health Canada
34278
Type II
2007/08/09
Stryker China Ltd
2518 6988
SA070830
Siemens Sonoline Antares and Acusion Antares Premium Edition
SA070831 Siemens Biograph 6 and Biograph 16
SA070832
SA070833
Stryker Peek Electrosurgical Handle
Radiometer D711 Reference Membrane ABL7XX
Health Canada
36506
Type II
2007/08/09
N/A
N/A
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
2877 3077
MHRA
2007/007/027/291/009
FSCA
2007/08/15
N/A
N/A
MHRA
MDA/2007/062
MDA
2007/08/15
2877 3077
MHRA
2007/008/010/061/012
FSCA
2007/08/16
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
SA070834 Getinge Castle Steam Sterilizers
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
51
SA070850
Abbott Embrace Enteral Pump
FDA
Z-1141-2007
Class II
2007/08/17
SA070851 Possis AngioJet XVG Thrombectomy Sets
FDA
Z-1131-2007
Class II
2007/08/17
N/A
N/A
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
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
2393 9511
Ltd
N/A
Action
2007/08/22
2960 7128
FDA
Z-1170-2007 to Z-1171-2007
Class II
2007/08/23
2806 4021
Kong
2738 2818
COOK PTFE Wire Guide with 3 cm flexible tip
SA070853 Philips Medical System Information Centre
SA070854
SA070855
SA070856
SA070857
SA070858
SA070859
2806 4021
Boston Scientific Precision Spare Suture Sleeve
Abbott CELL-DYN 1700 Hematology Analyzer
Lifescan One Touch SureSoft Lancing Device
FDA
Z-1165-2007
Class II
2007/08/23
Sendx Medical ABL77 Cal Pack, Model No. 944-069
FDA
Z-1173-2007
Class II
2007/08/23
FDA
Z-1132-2007 to Z-1134-2007
Class II
2007/08/23
2783 1838
FDA
Z-1172-2007
Class II
2007/08/23
N/A
N/A
FDA
Z-1175-2007 to Z-1177-2007
Class II
2007/08/23
N/A
N/A
MHRA
MDA/2007/065
MDA
2007/08/23
N/A
N/A
MHRA
2007/008/020/051/005
FSCA
2007/08/23
N/A
N/A
MHRA
MDA/2007/066
MDA
2007/08/23
N/A
N/A
2798 6080
SA070860 GE Medical System Mac-Lab System, CardioLab System,
ComboLab System
SA070861
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
SA070863 Hill-Rom TotalCare Duo 2
SA070864 Femcare Nikomed Unimax Disposable Shielded Trocar and
Cannula
SA070865 North Eos single-use Cusco screw type vaginal specula
SA070866 Depuy SmartSeal Pressurisers
MHRA
2007/007/016/061/005
FSCA
2007/08/27
SA070867 Biomet Optigun 4195
MHRA
2007/008/014/061/008
FSCA
2007/08/27
Kong
N/A
Health Canada
36667
Type I
2007/08/28
Gambro China Ltd.
2839 7010
Health Canada
33984
Type II
2007/08/28
2866 0811
Terumo Advanced Perfusion System - Modules
Health Canada
33985
Type II
2007/08/28
2866 0811
Terumo Advanced Perfusion System 1 and Central Control Monitor
Health Canada
33982
Type II
2007/08/28
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
N/A
Health Canada
33981
Type II
2007/08/28
2866 0811
Health Canada
36673
Type II
2007/08/28
2866 0811
Health Canada
36696
Type II
2007/08/28
2866 0811
Health Canada
36531
Type II
2007/08/28
2356 7033
Health Canada
36629
Type II
2007/08/28
Care Stream Health
2564 9751
52
SA070877 BD Procount Progenitor Cell
SA070878 BD Difco Shigella Antiserum Poly A1
SA070879 Steris Amsco Century Medium Steam Sterilizer & SFPP Steam
Sterilizer
SA070880
Dade Behring EasyLink Informatics System Software version 3.0
SA070881 Carmel PhaSeal Protector 14, 21 and 50 (Item No. P14, P21 and
P50)
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
N/A
FDA
Z-1174-2007
Class II
2007/08/30
N/A
N/A
FDA
Z-1178-2007 to Z-1181-2007
Class II
2007/08/30
N/A
N/A
53
MDCO Ref.
No.
SA070701 Abbott m2000sp Instrument and m1000 Instrument
Source of
Information*
MHRA
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
2007/006/020/601/002
FSCA
2007/07/03
2806 4201
Ltd
N/A
Action
2007/07/03
2960 7128
SA070703 Roche Cortisol Reagent
FDA
Z-0977-2007
Class II
2007/07/05
2485 7510
SA070704 GE Healthcare Diamond Mannographic X-Ray System
FDA
Z-0976-2007
Class II
2007/07/05
2783 1838
SA070705 Varian Medical LINAC Scapel Treatment Planning System
FDA
Z-0978-2007
Class II
2007/07/05
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
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
2876 7525
SA070709 Abbott ClearStar enteral feeding pump
MHRA
2007/006/025/061/002
FSCA
2007/07/05
2806 4201
SA070710 Baxter CS3000 Apheresis Kits
MHRA
2007/006/029/291/010
FSCA
2007/07/06
2807 8517
SA070711 Baxter Sample First Sampling System
MHRA
2007/007/002/291/004
FSCA
2007/07/06
2807 8517
SA070712 Varian Clinacs with Type 3 accessories
MHRA
2007/006/029/291/003
FSCA
2007/07/06
2724 2836
SA070713 Integra Neurosciences Elektrotm ET630 and ET621
MHRA
2007/007/003/291/024
FSCA
2007/07/06
N/A
N/A
SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters
SA070714
Boston Scientific VASOVIEWR UniportR Plus EVH System w/
Bisector VasoView 7xB Bisector
Ltd
N/A
Action
2007/07/09
2960 7128
SA070715
Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS
Chemistry System - Software
Health Canada
35306
Type II
2007/07/10
2738 2818
SA070716
Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel
System resolve Panel C
Health Canada
35880
Type II
2007/07/10
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
2814 4829
Health Canada
35874
Type II
2007/07/10
2806 4201
SA070722 Abbott Architect System - Analyzer - Class 2
Health Canada
35299
Type II
2007/07/10
2806 4201
SA070723 Elekta Precise Plan
Health Canada
35590
Type II
2007/07/10
N/A
N/A
SA070721
Abbott Axsym System - Quinidine Assay and X Systems Quinidine
Assay
54
SA070724 Gyrus CyberWand Ultrasonic Lithotriptor
Health Canada
35779
Type II
2007/07/10
N/A
N/A
SA070725 Chiltern Wispa Attachment Handle
Health Canada
34860
Type I
2007/07/10
N/A
N/A
SA070726 Airox Legendair Ventilator
Health Canada
35588
Type I
2007/07/10
Forever Health Medical Instrument Ltd
2770 9922
MHRA
2007/006/028/061/010
FSCA
2007/07/10
AMO Asia Limited
2480 3330
MHRA
2006/008/017/301/002
FSCA
2007/07/10
N/A
N/A
SA070729 AIDAPT Coniston Swivel Bathers
MHRA
2007/003/002/401/004
FSCA
2007/07/11
N/A
N/A
SA070730 AIDAPT Solo Bed Rail
MHRA
2007/004/024/291/010
FSCA
2007/07/11
N/A
N/A
FDA
Z-0848-2007 to Z-0852-2007,
Z-0928-2007
Class II
2007/07/12
2783 1838
FDA
Z-0991-2007
Class II
2007/07/12
FDA
Z-1002-2007 to Z-1005-2007
Class II
2007/07/12
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
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
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
SA070727 AMO VISX WaveScan WaveFront Systems
SA070728
SA070731
Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum
610, 1107
GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800
mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system
SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder
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
SA070743 Siemens CENTRA Active BTE Hearing Instrument
SA070744 BD Trypticase Soy Agar dehydrated culture media
SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth
SA070746 Boston Scientific Mach 1 Guide Catheter
Ltd
MHRA
2007/006/029/601/004
MHRA
2007/004/018/601/810
BD
MHRA
2007/007/005/051/003
Ltd
FSCA
2007/07/13
N/A
N/A
Action
2007/07/13
2960 7128
FSCA
2007/07/17
N/A
N/A
FSCA
2007/07/17
Siemens Ltd.
2810 7533
Action
2007/07/17
BD
2575 8668
FSCA
2007/07/18
N/A
N/A
Action
2007/07/18
2960 7128
SA070747 Terumo TenderFlow Pediatric Arterial Cannulae
FDA
Z-0874-2007 to Z-0885-2007
Class II
2007/07/19
2866 0811
SA070748 Abbott Patrol Enteral Pump Set
FDA
Z-0888-2007
Class II
2007/07/19
2806 4201
SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack
FDA
Z-1023-2007 to Z-1040-2007
Class II
2007/07/19
2806 4021
55
SA070750 Ossur Total Knee Model Number 2100
FDA
Z-1076-2007
Class II
2007/07/19
N/A
N/A
GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 CSA070751
Arm Fluoroscopic X-Ray System
FDA
Z-0989-2007 to Z-0990-2007
Class II
2007/07/19
2783 1838
FDA
Z-1043-2007 to Z-1044-2007
Class II
2007/07/19
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
Ltd
N/A
Action
2007/07/20
2960 7128
FDA
N/A
Press Release
2007/07/23
2807 8555
2007/07/24
N/A
N/A
SA070752
SA070755
GE Healthcare Innova 2100 IQ and Innova 3100/3100IQ
Fluoroscopic Imaging System
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
2485 7510
SA070759 Roche PSM QC and Validation Modules
Health Canada
35915
Type II
2007/07/25
2485 7510
SA070760 Philips Heartstart XL Monitor/Defibrillator
Health Canada
36081
Type II
2007/07/25
2876 7525
AGFA OT3000 Orthopaedic Workstation, MA3000 Mammographic
SA070761
Workstation, Impax DS3000
Health Canada
36232
Type II
2007/07/25
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
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
2724 2836
SA070766 Roche Amplilink
Health Canada
35912
Type II
2007/07/25
2485 7510
SA070767 Elekta Precise Destop Release 4.2/5.0
Health Canada
35828
Type II
2007/07/25
N/A
N/A
Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable
SA070768
Suture
Health Canada
36080
Type II
2007/07/25
N/A
N/A
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
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
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
56
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
MHRA
2007/002/001/401/009
FDA
57
FSCA
2007/07/27
2919 1362
Class I
2007/07/27
2807 8555
Monthly Summary of Medical Device Safety Alerts - June 2007
MDCO Ref.
No.
SA070601 Invacare Flamingo mobile patient hoists
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
MHRA
MDA/2007/043
MDA
2007/06/01
N/A
N/A
2807 8556
2376 1805
BD
2575-8668
2332 4455
Limited
2485 7510
2317 0988
2393 9511
N/A
N/A
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
N/A
2789 3300
N/A
N/A
N/A
N/A
2007/06/04
SA070602
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
Action
2007/06/04
SA070605
Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magill
endotracheal tube
Kimberly Clark Health
Care
N/A
Action
2007/06/04
SA070606 Roche COBAS Taqman HCV and HIV-1 Test
SA070607
Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User and
H-31B Air Detector/Clamp
p 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)
2007/06/04
MHRA
2007/005/031/061/014
FSCA
MHRA
2007/004/011/051/001
FSCA
MHRA
2007/005/031/051/010
FSCA
2007/06/05
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
35431
Type II
SA070613 Fujifilm FCR Velocity U and DR Velocity UFP
Health Canada
35223
Type II
SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair
Health Canada
34829
Type II
SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit
2007/06/06
2007/06/07
SA070612 Siemens AG Sienet Magicstore
SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer
2007/06/05
Health Canada
Health Canada
34820
Type II
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
Health Canada
35132
Type II
MHRA
2007/005/009/061/008
FSCA
MHRA
2007/005/031/051/005
58
FSCA
2007/06/12
2007/06/12
SA070620 BD Microtainer Safety Flow Lancets
2007/06/12
MDA/2007/049
MDA
SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit
Ltd
N/A
Action
2007/06/12
SA070622 Boston Scientific Impulse Angiographic Catheter
Ltd
N/A
Action
2007/06/12
MHRA
2007/006/006/061/023
FSCA
Class II
SA070623 ev3 Amplatz Goose Neck Snare Kit
SA070624 Wright Medical Profemur R, Revision Hip System
MHRA
FDA
Z-0867-2007 to Z-0868-2007
BD
2575 8668
2960 7128
2960 7128
2007/06/13
Conmed Ltd
2854 4413
2007/06/14
2381 0279
N/A
N/A
Limited
2485 7510
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
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
FDA
Z-0926-2007 to Z-0927-2007
Class II
MHRA
2007/004/017/601/805
FSCA
MHRA
MHRA
2007/006/005/051/020
2007/006/012/061/008
FSCA
FSCA
MHRA
2007/005/018/601/919
FSCA
Ltd
N/A
Action
SA070635 Biomet 3i EP Healing Abutment
FDA
Z-0922-2007
Class II
SA070636 Biomet 3i disposable twist drills
FDA
Z-0959-2007
Class II
SA070634 Boston Scientific Transend EX Guidewire
SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement
SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier
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
FDA
FDA
Z-0960-2007 to Z-0965-2007
Z-0935-2007
Class II
Class II
FDA
Z-0936-2007
Class II
MHRA
2007/005/025/061/005
FSCA
MHRA
2007/006/013/061/001
FSCA
Bausch & Lomb
(Hong Kong) Ltd.
N/A
Action
MHRA
2007/003/029/601/731
FSCA
59
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
2645 8703
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
2317 0988
SA070644 Sunrise Quickie
Health Canada
35442
Type II
SA070645 Airox Legendair Ventilator Single/Double Bran
Health Canada
35427
Type I
SA070646 Walter Lorenz Bone File
Health Canada
35636
Type II
SA070647 Beckman Coulter Flow Count Fluorospheres
Health Canada
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
2007/06/25
2007/06/25
N/A
N/A
Forever Health Medical Instrument Ltd
2770 9922
N/A
N/A
2240 6260
2240 6260
BD
2575 8668
SA070650 Inpeco Accelerator Aps System
Health Canada
35448
Type II
2007/06/25
N/A
N/A
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
N/A
N/A
N/A
N/A
2007/06/27
Ltd.
N/A
2007/06/27
/ /
N/A
N/A
2806 4201
2007/06/28
N/A
2007/06/28
Limited
2485 7510
N/A
N/A
2960 7128
2919 1362
N/A
N/A
GM Medical (Hong Kong) Ltd
2521 9799
SA070653 Edwards Lifesciences Vigilance II Monitor
MHRA
2007/006/013/061/012
FSCA
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
Abbott ARCHITECT i2000 Processing Module (List# 08C89-01,
SA070657
3M74-01, 1G06-01 & 3L77-01)
FDA
Z-0950-2007 to Z-0953-2007
Class II
SA070658 Steris QFC1728 and QFC1729 Quick Connects
FDA
Z-0967-2007
Class II
SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit
2007/07/26
2007/06/28
FDA
Z-0956-2007
SA070660 Invacare Scanbed 750 (SB750)
MHRA
MDA/2007/056
MDA
2007/06/28
SA070661 Boston Scientific Capio Sutures
Ltd
N/A
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)
Class II
2007/06/25
MHRA
2007/006/026/291/013
FSCA
Cyberonics
N/A
Action
60
2007/06/29
2007/06/29
2007/06/29
Monthly Summary of Medical Device Safety Alerts - May 2007
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA070501 ResMed S8 CPAP Devices
MHRA
2007/004/025/291/009
FSCA
2007/05/02
N/A
N/A
SA070502 Medi Prosthetic Knee Joint
FDA
Z-0759-2007
Class II
2007/05/03
N/A
N/A
N/A
N/A
2960 7128
Kong
2738 2818
2240 6260
MDCO Ref.
No.
SA070503 Endoart EasyBand
Boston Scientific NexStentR Carotid Stent and Monorail Delivery
SA070504
System
2007/004/020/291/007
FSCA
2007/05/03
Boston Scientific (HK)
Ltd
N/A
Action
2007/05/03
MHRA
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
SA070508 Baxter UV Flash Compact Device
SA070509 Hill-Rom
Rom AvantGuard
AvantGuard Electtic
Electtic Bed
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)
Instrumentation Laboratory GEM Premier 4000 Laboratory
SA070513
Analyzer
SA070511
SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator
SA070515
American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro
diagnostic
Tyco Healthcare SealGuard TracheoSoft and SealGuard
SA070516
TracheoSoft PERC
SA070517
Edwards Lifesciences CO-Set + Closed Injectate Delivery System
for Cold Injectate (Model 93600)
MHRA
MHRA
2007/005/002/061/009
2006/009/004/291/005
FSCA
FSCA
FDA
Z-0773-2007 to Z-0776-2007
Class II
FDA
Z-0771-2007
Class II
FDA
FDA
FDA
FDA
MHRA
Z-0783-2007
Z-0778-2007
Z-0772-2007
Z-0779-2007
2006/011/016/291/003
Class II
Class II
Class II
Class II
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
2007/003/029/291/013
FSCA
SA070518 AFOS All endoscope storage facilities (ESF)
MHRA
MDA/2007/035
Medical Device Alert
SA070519 Olympus Flexible endoscopes
MHRA
MDA/2007/034
2007/05/11
Action
2007/05/11
SA070521 JCM Supportive seating system
2645 8703
28078556
N/A
N/A
2356 7033
Sanko Medical Systems (H.K.) Ltd.
2384 0688
2277 6125
Vastec medical Ltd
2897 1912
N/A
N/A
N/A
N/A
3157 7244
N/A
N/A
N/A
N/A
2376 1805
2919 1362
N/A
N/A
2007/05/10
MHRA
SA070520 Medtronic MiniMed insulin infusion pumps
Medtronic
International, Ltd.
MHRA
N/A
2006/010/012/301/003
61
FSCA
2007/05/11
2007/05/11
SA070522 Thoratec - Paracorporeal ventricular assist device
Health Canada
34992
Type I
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
SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter
SA070530
Boston Scientific System Drape (IVUS motor drive sterile plastic
cover)
SA070531 Medical Wire and Equipment Customers Microrings
SA070532 Arjo Maxi Move Patient Lift with Scale
SA070533 Et
SA070533
Ethi
hicon Gynecare PROLIFT Tota
t l Pelvic Repair System
t
SA070534 CIBASoft Visitint Soft Contact Lenses
Health Canada
Health Canada
Health Canada
Ltd
Ltd
MHRA
FDA
FDA
FDA
34868
Type II
34958
Type II
Action
N/A
2007/005/003/061/014
Z-0796-2007 to Z-0799-2007
Z-07950795 2007
2007
Z-0793-2007
FSCA
Class II
Class II
Class II
2007/005/011/291/002
FSCA
SA070541 Conor Medsystems CoStar drug-eluting coronary stents
SA070542
Homecraft Rolyan Bathmaster 2000, Bathmaster Classic,
Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls)
SA070543 Nightingale Pro Axis and Pro Axis Plus
MHRA
MHRA
2007/005/010/291/006
2007/005/010/061/013
2007/005/010/061/009
2007/004/025/291/018
FSCA
FSCA
FSCA
FSCA
Johnson & Johnson
N/A
N/A
MHRA
MDA/2007/039
MHRA
MDA/2007/038
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
SA070546
Viasys all paediatric ventilator breathing systems containing water
trap
MHRA
2007/05/14
2007/05/15
MHRA
DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18SA070540
90-180 & NDC-18-110-180)
2007/05/14
N/A
SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp
SA070539 Olympus Triglyceride Reagent
2007/05/14
2007/05/15
FSCA
MHRA
2007/05/14
Type II
2007/005/002/061/006
SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A
2007/05/14
Action
MHRA
MHRA
2007/05/14
34918
SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor
SA070537 BD FACSCanto and FACSCanto II Software
2007/05/14
MDA/2007/037
62
2007/05/15
2007/05/17
2007/05/17
2007/05/17
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
2007/05/22
2007/05/22
2007/05/22
2007/05/22
GM Medical Pacific Ltd
2783 1838
2783 1838
2783 1838
2783 1838
N/A
N/A
N/A
N/A
Stryker China Ltd
2518 6988
2960 7128
2960 7128
N/A
N/A
2508 9553
Kong
2738
27
38 2818
Ciba Vision (Hong Kong) Ltd.
2814 2121
2919 1362
N/A
N/A
BD
2575 8668
2376 1805
2376 1805
N/A
N/A
Biotronik Hong Kong
2877 6787
N/A
N/A
N/A
N/A
2317 0988
N/A
N/A
2893 0873
SA070547 Abbott FLEXIFLO DURA-PEG Kit
SA070548 Cranex Tome panoramic x-ray unit
SA070549
GE Americas Signa 3.0T EXCITE Whole Body Magnetic
Resonance System
SA070550 BioMerieux BacT/VIEW Software, all versions.
SA070551 Diagnostic Stago STA Compact and STA Compact CT
MHRA
FDA
FDA
FDA
FDA
2007/005/014/061/019
Z-0816-2007
Z-0815-2007
Z-0814-2007
Z-0812-2007
FSCA
Class II
Class II
Class II
2007/05/23
2007/05/25
2007/05/25
2007/05/25
2806 4201
Umedco
2765 8222
2783 1838
2356 7033
Class II
2007/05/25
N/A
N/A
Limited
N/A
2485 7510
2877 3077
GNB Technologies (China) Ltd
N/A
FDA
Z-0810-2007
Class II
2007/05/25
SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs
MHRA
2007/004/010/301/003
FSCA
2007/05/25
SA070554 Draeger Medical Primus anaesthetic workstation
MHRA
MDA/2007/040
SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger
MHRA
2007/002/001/301/001
FSCA
2007/05/25
N/A
Action
2007/05/25
2806 4201
AMO Asia Limited
2480 3330
Limited
N/A
2485 7510
SA070552 Roche PTH (Parathyroid Hormone Test system )
SA070556 Abbott ARCHITECT STAT Troponin-I test products
Abbott Laboratories
Ltd.
2007/05/25
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
y I
2007/05/28
SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution
N/A
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
2277 6125
SA070562 Dentsply Protper Obturators
Health Canada
34652
Type II
2007/05/28
N/A
N/A
2876 7525
2876 7525
N/A
N/A
2240 6260
N/A
N/A
2919 1362
BD
2575 8668
N/A
N/A
2783 1838
2806 4201
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
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.
SA070567 BIODIS VerifyNow P2Y12
SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760
SA070569 BD Infusion Therapy System (Angiocath Catheter)
Health Canada
35032
Type II
2007/05/28
Health Canada
35003
Type II
MHRA
2007/003/026/291/004
FSCA
Medtronic
International, Ltd.
Action
Action
N/A
BD
N/A
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
SA070572 Abbott Precision Link Software (version 2.1 - 2.6)
FDA
Z-0709-2007
Class II
2007/05/28
2007/05/28
2007/05/29
2007/05/29
2007/05/29
2007/05/31
63
2007/05/31
2007/05/31
SA070573 CP Medical Surgical Suture
SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem
FDA
Z-0807-2007
Class II
2007/05/31
N/A
N/A
MHRA
2007/005/022/061/006
FSCA
2007/05/31
N/A
N/A
64
Monthly Summary of Medical Device Safety Alerts - April 2007
MDCO Ref.
No.
Source of
Information*
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
2783 1838
SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups
MHRA
2007/002/006/081/001
FSCA
2007/04/03
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
2783 1838
SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select
Health Canada
33345
Type II
2007/04/10
2783 1838
Health Canada
345,133,451,434,517
Type II
2007/04/10
2783 1838
Health Canada
34484
Type II
2007/04/10
2783 1838
Health Canada
33329
Type II
2007/04/10
2783 1838
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
2317 0988
SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump
Health Canada
34277
Type II
2007/04/10
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
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
Action
2007/04/10
2919 1362
SA070401
SA070405
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
SA070409 (1) Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800
(5) 9800
SA070410 GE Healthcare - Instatrak 3500 System
SA070408
65
2738 2894
SA070421 Philips Medical - Brilliance Computed Tomography System
Health Canada
34499
Type II
2007/04/10
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
SA070423
Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular
stapler
Johnson & Johnson
Medical Hong Kong
N/A
N/A
2007/04/10
2738 2818
SA070424
Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY
and VITALITY 2 (ICD)
Ltd
N/A
Action
2007/04/11
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
2992 0968
SA070430 Siemens syngo Dynamics 5.0 Workplace
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
2992 0968
FDA
Z-0655-2007 to Z-0659-2007
Class II
2007/04/11
2866 0811
SA070431
Zimmer NexGen Complete Knee Solution Minimally Invasive
Solutions MIS Technology Femoral Finishing Guid
SA070432 Terumo Perfusion System 8000 Base, Model 8000
SA070433 Cook ATB Advance
Advance PTA Dilation
Dilation Catheter
Catheter, REF G26887
SA070434 BD 366358 LANSCET SFL GREEN
FDA
((1)) Cook Asia (Hong
(
g Kong)
g) Ltd.;; ((2)) ((1)) 2781 0232;; (2)
( )
2541 1041
Z-0665-2007
Class II
Class
2007/04/11
BD
N/A
Action
2007/04/11
BD
2575 8668
SA070435
Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer users
and Level 1 H31-B Air Detector/ Clamp User
MHRA
2007/003/028/081/005
FSCA
2007/04/11
2317 0988
SA070436
Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument Part
Number: 400172-04
FDA
Z-0660-2007
Class II
2007/04/11
N/A
N/A
Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no
SA070437
7D71-30 and 7D71-20)
FDA
Z-0722-2007
Class II
2007/04/12
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
2806 4201
SA070440
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
SA070441
Cenorin ThermaSure Medical Device Drying Cabient series 130,
300 AND 1000
FDA
Z-0711-2007 to Z-0713-2007
Class II
2007/04/12
N/A
N/A
Radiometer America ABL800 FLEX Series analyzer with FLEXQ
SA070442
module-equipped with software version 5.2 to 5.27
FDA
Z-0705-2007
Class II
2007/04/12
N/A
N/A
Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001761)
FDA
Z-0701-2007
Class II
2007/04/12
N/A
N/A
FDA
SA070443
SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0
Z-0720-2007 to Z-0721-2007
Class II
2007/04/12
N/A
N/A
Boston Scientific Percutaneous Track Kit with Amplaz Dilator and
SA070445
Sheath Kit
Ltd
N/A
Action
2007/04/16
2960 7128
SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System
Ltd
N/A
Action
2007/04/16
2960 7128
66
Ltd
N/A
Action
2007/04/16
2960 7128
SA070448 HemoCue Glucose Systems
MHRA
2007/033/019/291/006
FSCA
2007/04/16
2543 7442
SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60)
MHRA
2007/004/002/601/745
FSCA
2007/04/16
2806 4201
LifeScan United
Kingdom and Ireland
N/A
N/A
2007/04/17
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
SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators
SA070450 LifeScan One Touch Ultra blood glucose test strips
SA070451
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
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
2485 7510
SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322)
FDA
Z-0736-2007
Class II
2007/04/19
2485 7510
Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP
SA070457
450 Test, CE-IVD, M/N4381866190
FDA
Z-0734-2007 to Z-0735-2007
Class II
2007/04/19
2485 7510
SA070458 Bio-Rad tox/See Drug Screen Test
FDA
Z-0733-2007
Class II
2007/04/19
2789 3300
AMS DURA-II Distal Tips and Universal Tips (Product no 72009340
SA070459
and 72009361))
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
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
MHRA
2007/004/010/131/006
FSCA
2007/04/20
N/A
N/A
CONMED LTD
2854 4413
SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200)
MHRA
2007/004/013/051/003
FSCA
2007/04/20
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
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
Health Canada
34068
Type II
2007/04/23
2919 1362
MHRA
2007/004/012/601/784
FSCA
2007/04/23
2806 4201
MHRA
2007/003/016/081/007
FSCA
2007/04/23
N/A
N/A
Ltd
N/A
Action
2007/04/23
2960 7128
Varian Medical
N/A
Action
2007/04/23
2724 2836
MHRA
2007/004/017/601/800
FSCA
2007/04/24
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
Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01
SA070470 and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25,
7K60-30)
Unomedical Drain-Fix 680M and 685M, Central Gard 667M and
SA070471
668M , Epi-Fix 670M
SA070472 Boston Scientific SypGlassT Light Source
Varian OBI with cone beam computed tomography (Versions 1.2
and 1.3)
AxSYM Total β - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A06SA070474
22) and Speciment Diluent (List no. 9C21-50)
SA070475 Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422
SA070473
SA070476 Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580T2ASM2
67
SA070477 RITA Starburst XL, Starburst, Starburst MRI SemiFlex
FDA
Z-0752-2007 to Z-0754-2007
Class II
2007/04/27
N/A
N/A
SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363)
FDA
Z-0749-2007 to Z-0751-2007
Class II
2007/04/27
Siemens Ltd.
2810 7533
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
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
Infusion Pump.
SA070485 Toshiba Aplio XV Ultrasound System
Health Canada
34838
Type II
2007/04/30
2876 7525
Health Canada
34787
Type II
2007/04/30
2807 8556
Health Canada
34318
Type II
2007/04/30
2384 0688
Siemens Linear Accelerators, Digital Linear Accelerator and Oncor
SA070486
Impression IMRT
Health Canada
34725
Type II
2007/04/30
Siemens Ltd.
2810 7533
SA070487 Maquet HL30 Perfusion System
Health Canada
34587
Type II
2007/04/30
2393 9511
Health Canada
34794
Type II
2007/04/30
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
SA070480 BIO-RAD EVOLIS SYSTEMS
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
p
g
circulating
SA070491 西安西京醫療用品有限公司"希健醫用" Extracorporeal
set
68
Monthly Summary of Medical Device Safety Alerts - March 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No
SA070301 Taut Intraducer Peritoneal Catheter
FDA
Z-0428-2007
Class II
2007/03/01
N/A
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
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
SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625
FDA
Z-0554-2007
Class II
2007/03/01
N/A
N/A
SA070305 Arjo - Sara Active Sling, patient Lift
FDA
Z-0424-2007 to Z-0426-2007
Class II
2007/03/01
2508 9553
MHRA
2007/001/025/081/004
2007/03/01
N/A
N/A
2007/03/01
BD
2575 8668
2007/03/02
N/A
N/A
SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine
SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435)
SA070308 Kjaerulff Lift Stand Aid (art no: 400640434)
BD
MHRA
N/A
2006/09/006/401/013
Field Safety Corrective
Action
Action
Action
SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000
Health Canada
34055
Type II
2007/03/05
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
Action
2007/03/05
N/A
N/A
MHRA
2007/002/014/081/006
Action
2007/03/06
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
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
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
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)
69
Medronic International Ltd
2919 1362
SA070323
LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223
(Code C6310, C6324 and C6297)
SA070324
Preservation Uni-Compartmental Knee fixed-bearing Tibial Tray
Components (size 1 - 5 )
SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation
FDA
Z-0546-2007
MHRA
2006/011/022/081/001
MHRA
2007/002/001/081/014
Class II
Action
Action
2007/03/08
N/A
N/A
2007/03/08
DePuy Inc (J&J)
2007/03/08
DePuy Inc (J&J)
2007/03/08
N/A
N/A
2738 2894
2738 2894
SA070326 ConMed Frazier and Poole Suction Instruments
MHRA
2006/011/023/081/011
Action
SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans
MHRA
2006/012/007/081/004
Action
2007/03/08
N/A
N/A
Ltd
N/A
Action
2007/03/09
2960 7128
SA070329 Timesco Optima XL Stubby Laryngoscope Handles
MHRA
2006/012/001/291/002
Action
2007/03/09
N/A
N/A
SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A)
MHRA
2007/003/001/181/002
Action
2007/03/09
N/A
N/A
2007/003/008/081/001
Action
2007/03/12
N/A
N/A
2007/03/13
N/A
N/A
2007/03/14
2240 6260
SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs)
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
2006/011/001/081/009
Action
Field
Fie
ld Safety Corrective
Action
SA070333 Beckman Coulter FP1000 Cell
Cell Preparation System
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
2007/03/14
N/A
N/A
Hamilton Medical
N/A
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
2381 0279
FDA
Z-0574-2007
Class II
2007/03/15
N/A
N/A
MHRA
2007/003/007/601/661
2007/03/15
N/A
N/A
Ltd
N/A
2007/03/15
2960 7128
SA070335 Hamilton Medical Galileo Classic and Gold ventilators
SA070336
Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray
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
70
Action
Action
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)
SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN
SA070348
SA070349
SA070350
SA070351
SA070352
SA070353
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
SA070354 Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01)
SA070355
SA070356
SA070357
SA070358
SA070359
SA070360
SA070361
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System
(Catalog # 164268)
Baxter Healthcare Corp - Clearlink Paclitaxel IV Ad
Admin
min 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
SA070368
Smith & Nephew InterTan Subtrochanteric Lag Screw Driver
(Product Code: 71674068)
SA070369 GE Healthcare OEC 9800
SA070370
Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys
Phacoemulsificator
MDA/2007/023
2007/03/16
2007/003/012/081/010
Action
2007/03/16
2007/003/013/081/005
Action
2007/03/20
N/A
N/A
2007/003/012/601/683
Action
2007/03/20
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
FDA
Z-0637-2007
Class II
2007/03/21
FDA
Z-0616-2007
Class II
2007/03/21
2876 7525
FDA
Z-0639-2007
Class II
2007/03/21
2806 4201
FDA
Z-0617-2007
Class II
2007/03/21
2866 0811
Class II
Class
2007/03/21
Ba ter Healthcare Ltd
Baxter
2807 8556
Action
Action
Action
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
2356 7033
2007/03/21
2393 9511
Action
2007/03/21
N/A
N/A
MHRA
MHRA
MHRA
MHRA
H lth Canada
Hea
d
34385
2960 7128
2645 8703
(1) Cook Asia (Hong Kong) Ltd.; (2) (1) 2781 0232; (2)
2541 1041
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
MHRA
2006/003/014/291/019
FDA
Z-0594-2007
Class II
2007/03/21
N/A
N/A
BD
N/A
Action
2007/03/21
BD
2575 8668
Ltd
N/A
Action
2007/03/22
2960 7128
Varian Medical
N/A
Action
2007/03/22
2724 2836
MHRA
2006/009/019/181/013
Action
2007/03/26
N/A
N/A
MHRA
2007/001/017/291/001
2007/03/26
MHRA
2006/010/013/291/005
2007/03/26
2783 1838
MHRA
2007/001/016/081/010
2007/03/26
N/A
N/A
71
Action
Action
Action
2738 2894
2645 8703
SA070371
BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached
Holders
SA070372 Puritan Bennett 840 Ventilator System
SA070373
SA070374
SA070375
SA070376
SA070377
SA070378
Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3,
length tubing (batches C8218)
Boston Scientific Polarcath Peripheral Dilatation System Inflation
Unit
Viasys VELA Ventilator
BioMerieux BacT/ALERT FA Culture Bottles
BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1)
diagnostic data management system
Gebauer - Salivart Oral Moisturizer
MHRA
2007/003/020/601/694
Ltd
FDA
FDA
Z-0638-2007
Z-0643-2007
Action
Action
Action
Action
Class II
Class II
FDA
Z-0644-2007
Class II
2007/03/29
2356 7033
Class II
Action
Action
Action
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
Class I
2007/03/30
N/A
N/A
BD
N/A
MHRA
2007/003/021/081/002
N/A
FDA
Z-0497-2007
SA070379 Immucor Gamma Capture-R Select plates
MHRA
2007/001/002/291/001
SA070380 CPS Direct SL slittable outer guide catheter
MHRA
2007/003/021/081/003
SA070381 Arcomedical Ltd - 3101PNOY (FSB542) (Batch number C7944)
MHRA
2006/009/029/401/001
FDA
Z-0622-2007 to Z-0626-2007
SA070382 HoMedics Thera-P Heating Pads
72
2007/03/27
BD
2575 8668
2007/03/28
3157 7244
2007/03/28
N/A
N/A
2007/03/29
2960 7128
2007/03/29
2007/03/29
2893 0873
2356 7033
Monthly Summary of Medical Device Safety Alerts - February 2007
MDCO Ref.
No.
Source of
Information*
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
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
2806 4201
Terang Nusa Sterile Neolon 2G Latex-Free
Latex-Free Powder-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
2876 7525
FDA
Z-0373-2007
Class II
2007/02/01
2783 1838
FDA
Z-0376-2007
Class II
2007/02/01
2789 3300
FDA
Z-0377-2007
Class II
2007/02/01
2007/02/02
Cyberonics VNS Therapy System, Model 250-'HAND HELD'
SA070201 programming software v6.1, v6.1.7, v7.0, v7.1.3 & 2500'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0,
7 1 3 - Jostra Heater Cooler Unit HCU30, System version 1.02Maquet
SA070202 Low voltage machin, Article no.: 0704629 (serial no. 101006 101024)
Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat.
SA070203
No 511-20 (Lot#29892)
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
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
SA070215
Lucas external cardiac compressor, manufactured by Jolife AB and
distributed by Medtronic Ltd
MHRA
N/A
2393 9511
(1) Cook Asia (Hong Kong) Ltd. (2) (1) 2781 0232; (2)
2541 1041
Boston Scientific
2960 7128
2007/02/05
N/A
N/A
2007/02/06
BOC Gases, Hong Kong Oxygen &
Acetylene Co Ltd (HKO)
2372 2288
MDA/2007/013
2007/02/07
2919 1362
2783 1838
GE Healthcare - Computed tomography - LightSpeed VCT SA070216 Discovery VCT - LightSpeed Pro32 - LightSpeed Pro 16 LightSpeed RT16/ LightSpeed Xtra
SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set
MHRA
2007/001/031/121/003
Action
2007/02/07
Health Canada
33352
Type II
2007/02/07
2724 2836
SA070218 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/7)
Health Canada
32880
Type II
2007/02/07
2384 0688
SA070219 Walter Lorenz- 2" QC Solid Shaft Extention
Health Canada
33542
Type II
2007/02/07
N/A
N/A
73
SA070220
Spacelabs Medical - Ultraview SL Command Module
(Model/Catalog#91496)
Health Canada
33638
Type II
2007/02/07
Schmidt BioMed Tech (HK) Ltd
2620 8310
SA070221 GE Healthcare - Innova 2100 IQ
Health Canada
33717
Type II
2007/02/07
2783 1838
SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits
Health Canada
33803
Type II
2007/02/07
Tokibo Co. (Hong Kong) Ltd
2418 9698
SA070223 Tyco Healthcare- CT9000 ADV with Console
Health Canada
33834
Type II
2007/02/07
3157 7244
Health Canada
33570
Type I
2007/02/07
2356 7033
Biomerieux - Vironostika HIV-1 Microelisa System
(Model/Catalog#259605; Lot/Serial#160354)
SA070225 Misys Healthcare System Version 6.1 and 6.2
SA070224
Health Canada
32993
Type II
2007/02/07
N/A
N/A
SA070226
VISX Incorporated - Wavescan Wavefront System (Model/Catalog
HS-1)
Health Canada
33201
Type II
2007/02/07
VISX Incorporated (HK)
N/A
SA070227
Dentalez Inc. Stardental Division - Solara Replacement Turbine
(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
Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070229
8000D)
Health Canada
33121
Type II
2007/02/07
2384 0688
SA070230
Terumo Advance Perfusion System 1 Integrated Centrifugal
System Control Unit (Catalog#801046)
FDA
Z-0381-2007
Class II
2007/02/08
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
Action
2007/02/08
2807 8556
SA070236
Boston Scientific - Urgent Medical Device Recall - Immediate
Action Required: Matrix 2
Ltd
Action
2007/02/09
2960 7128
SA070237
Medtronic - Spinal Implants - Colorado 2 Anterior Plates # 8639500
& #8619500
MHRA
2007/002/006/291/007
Action
2007/02/12
2919 1362
SA070238
Abbott - StarClose Vascular Closure System (Catalogue# 14677;
Lot # 43034-6H to 47139-6H)
MHRA
2007/002/005/081/014
Action
2007/02/12
2806 4201
SA070239
Bayer - Benzodiazepine Reagent Lot 56510483 used with ADVIA
1200, 1650, 1800 and 2400 Chemistry System
MHRA
2007/001/015/081/013
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
2007/02/13
2317 0988
MHRA
MDA/2007/016
2007/02/13
Direct Health Ltd
2528 1109
MHRA
2007/002/001/081/008
Action
2007/02/14
2919 1362
FDA
Z-0415-2007 to Z-0416-2007
Class II
2007/02/15
2806 4201
SA070241 Invacare C800 Series ceiling track
SA070242 Medtronic - Vitatron T and C pacemakers
SA070243
Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 &
3M74-01; Temp Controller Board Par#78560-109&7856-109)
74
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
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
2240 6260
FDA
Z-0396-2007
Class II
2007/02/15
N/A
N/A
SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor
MHRA
MDA/2007/017
2007/02/15
Welch Allyn
N/A
SA070248 Draeger Infinity monitor with Infinity docking station(IDS)
MHRA
MDA/2007/018
2007/02/15
2877 3077
SA070249 GE Healthcare - Ventilator - Engstom Ventilator
MHRA
2007/002/008/601/579
2007/02/15
2783 1838
SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console
MHRA
2007/002/005/081/012
2007/02/15
N/A
N/A
SA070246
Perry-Kolberg Tiatanium Motility/Support System (Model 100045)
(Lot# M-50021)
Action
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
SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit
Health Canada
33815
Type II
2007/02/21
2876 7525
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
SA070256
Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B;
Lot/Serial# 6770192, 6770192F)
SA070262
GE Healthcare - Precision RX/I Fluoroscopic X-Ray System
(Model/Catalog#S1303JJ/JK/JL/JM)
Health Canada
32633
Type II
2007/02/21
2783 1838
SA070263
GE Healthcare - Precision 500D (Model/Catalog#S0915KE,
S0915KF)
Health Canada
32382
Type II
2007/02/21
2783 1838
SA070264
Ortho- Clinical Diagnostics - Fetalscreen Test for D(RHO) Positive
Fetal Red Blood Cells (Model/Catalog#780540) (Recall#33595)
Health Canada
33595
Type II
2007/02/21
Kong
2738 6162
SA070265
Williams Medical Suppliers Plc - Comfisound (Code: D52208,
D52209, 69.2100)
MHRA
2007/002/014/401/013
Action
2007/02/21
N/A
N/A
2007/002/015/081/004
Action
2007/02/21
Cemma Enterprise Co Ltd
2412 2310
American medical System- AMS700 Penile Prosthesis (Part no:
SA070266
72402987; Lot 475485004)
MHRA
75
Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right
SA070267 (Product codes: 71800508 & 71800513) (Lots# 06CM17723 &
06CN15086)
MHRA
2007/001/016/081/012
MHRA
2007/001/029/081/010
SA070269 Cardinal Health - Alaris Div -Syringe pumps (Signature Edition)
MHRA
2006/008/029/081/009
Conmed DetachaTip endoscopic Multiple use grasper and
SA070270 disposable hand held graspers and dissectors (Ratcheted and nonratcheted)
MHRA
MDA/2007/019
Health Canada
34026
SA070268
Candela - Vbeam/Aesthetica, Platiunum and Perfecta model laser
systems
SA070271 Durex Canada - Confirm Clearly Smart Pregnancy Test
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
Action
2007/02/21
2007/02/21
N/A
N/A
2007/02/21
N/A
N/A
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
Action
Action
Action
Action
2645 8730
SA070274
Clearview Simplify D- Dimer( Product code 505285; Kit Lot
numbers: PT030A & PT031A)
MHRA
2007/002/020/291/014
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
Action
2007/02/26
2806 4201
SA070276
Intavent Orthofix Ltd - Flexible size 2.5 Laryngeal Masks (REF
7125R and 7125DR)
MHRA
2007/002/013/081/009
Action
2007/02/27
N/A
N/A
MHRA
2007/002/019/121/006
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)
76
Monthly Summary of Medical Device Safety Alerts - January 2007
MDCO Ref.
No.
Source of
Information*
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
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
801764
FDA
Z-0314-2007 & Z-0315-2007
Class II
2007/01/03
2866 0811
SA070105
Posterior Acetabular Retractor-Left with Light Cord Bracket, Model
#BIO-1-1050-A, Posterior Acetabular Retrator-Right with Light Cord
Bracket, Model #BIO-1-1050-A, packaged 1 retractor (left or right
retractor) per plastic bag
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
3000/N
MHRA
2007/001/003/081/001
2007/01/04
Siemens Ltd.
Ltd.
2870 7533
SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys
MHRA
2006/010/023/601/367
2007/01/04
2783 1838
SA070109 Siemens AG Magicsas/Sienet IWM
Health Canada
33372
Action
A ti
Action
Action
Type II
2007/01/08
Siemens Ltd.
2870 7533
Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot
SA070110
1263830)
Health Canada
33320
Type II
2007/01/08
2317 0988
Class I
2007/01/10
2738 6080
Class I
2007/01/10
K
SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips
FDA
SA070112 Bard Composix Kugel Large Sized Patches
FDA
801040
SA070114 Philips Medical Systems HeatStart FR2+ Defibrillator,
SA070113
Z-0266-2007
FDA
Z-0292-2007 & Z-0293-2007
Class II
2007/01/10
2866 0811
FDA
Z-0308-2007
Class II
2007/01/10
2876 7525
FDA
Z-0322-2007 & Z-0337-2007
Class II
2007/01/10
2866 0811
FDA
Z-0338-2007
Class II
2007/01/10
N/A
N/A
FDA
Z-0339-2007
Class II
2007/01/10
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
Puritan Bennett KngithStar 330 Bi-Level Ventilator, Catalogue No.
SA070119 Y-KS330-NA. Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD,
DLY-KS330-NA & DLY-KS330-SD
FDA
Z-044-2007
Class II
2007/01/10
3157 7244
Bayer Advia 70 Hematology Analyzer, Drew Excell 22 Hematology
Analyzer
FDA
Z-0448-2007 & Z-0449-2007
Class II
2007/01/10
2814 4829
SA070115 Terumo Advanced Perfusion System 1
Edwards LifeSciences-Swan-Ganz, Thermodilution Venous
SA070116 Infusion Port(VIP) Catheter with AMC Throboshield (An
Antimicrobial *Heparin Coating), Ref: 831HF75, Model 831FH75
SA070117
SA070120
Smiths Medical ASD Inc. Bivona Laryngectomy Tube, ID 8.5mm,
O.D. 11mm Length 88mm, TTS 11.8mm
2645 8703
77
SA070121
Abbott Laboratories, Inc. Phenobarbital-Reagent-Clinical
Chemistry, List no. 1E08-20
FDA
Z-0454-2007
Class II
2007/01/10
2806 4201
SA070122
Integra LifeSciences BOLD/INI-CLIP 2.2mm Drill Bit with AO
Attachment. Model/Catalog No. 159004ND
FDA
Z-0466-2007
Class II
2007/01/10
N/A
N/A
SA070123
Shenzhen Bestman Instrument Media Injectors (X-ray) contrast
medium syringe
MHRA
2006/011/022/401/015
Action
2007/01/10
N/A
N/A
MHRA
2006/010/002/601/324
Action
2007/01/10
N/A
N/A
Health Canada
33715
Type II
2007/01/16
CIBA Vision (Hong Kong) Ltd.
2814 2121
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
SA070125 6721262 with expiration dates starting from 2011/09 to 2011/11,
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-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
FDA
Z-0482-2007
Class II
2007/01/17
2508 9553
FDA
Z-0486-2007
Class II
2007/01/17
Socofar Ltd
2861 3261
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
2807 8517
Medtronic
International, Ltd.
N/A
N/A
2007/01/22
2919 1362
SA070135 Toshiba - Xario Main Unit (Model # SSA-660A)
Health Canada
32878 and 33122
Type II
2007/01/22
2384 0688
Toshiba - Digital Fluorography System (Model or Catalog # DFPSA070136
8000D)
Health Canada
33123
Type II
2007/01/22
2384 0688
Health Canada
32870
Type II
2007/01/22
2384 0688
SA070138 Toshiba - X-Rays High Voltage Generator
Health Canada
33118
Type II
2007/01/22
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
2876 7525
2007/01/22
Kong
2738 2818
SA070129
Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part
#700.08310-24' and Part #700.08320-36')
Ossur - Re-Flex VSP and Low Profile Re-Flex VSP external
SA070130 prosthetic foot modules (Model no.: RFXS0002, RFXS0003,
RFLS0006 and RFL50007
Stryker - Simplex P with Tobramycin Anitibiotic PMMA Bone
Cement
Varian Medical Systems GammaMed 12i and 12t radionuclide
SA070132
applicator systems
SA070131
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)
SA070142 Cordis Prowler Infusion Catheter
Health Canada
32189
Type II
78
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
Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2)
SA070146
R2 and Immunoglobulin G (IGGT) Assay
SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100
Health Canada
33251
Type II
2007/01/22
JOINHANDS TECH LTD
2635 3455
Health Canada
33587
Type II
2007/01/22
2877 3077
Health Canada
33400
Type II
2007/01/22
Health Canada
32922
Type II
2007/01/22
2485 7510
Health Canada
33046
Type II
2007/01/22
N/A
Limited
2783 1838
N/A
SA070148
I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or
Catalog#PM012 )(Lot or Serial # 662449, 662742)
Health Canada
33058
Type I
2007/01/22
N/A
N/A
SA070149
Airox Legendair Ventilator (Lot or Serial# All Airox Legendair
Ventilator LE030007, EXPECT LE020007, LE021009)
Health Canada
33211
Type I
2007/01/22
N/A
N/A
MHRA
2006/012/021/601/481
Action
2007/01/22
2783 1838
SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System
SA070151
Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting
Balloon
Health Canada
33497
Type II
2007/01/22
N/A
N/A
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
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
Action
2007/01/25
2240 6260
MHRA
2007/001/008/081/007
Field Safety
y Corrective
Action
2007/01/25
Varian Medical
Medical Systems Pacific Inc
Inc.
2724 2836
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry
SA070155 Systems, Automated Clinical Chemistry Analyzer - human serum,
plasma and urine tests
FDA
Z-0351-2007 to Z-0353-2007
Class II
2007/01/25
2814 4829
SA070156 Abbott Spine TraXis Fixed Trail and TraXis Fixed Rasp
FDA
Z-0354-2007 to Z-0355-2007
Class II
2007/01/25
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
Ltd
N/A
Action
2007/01/26
2960 7128
MHRA
MDA/2007/2008
2007/01/30
N/A
N/A
MHRA
2006/007/027/401/003
Action
2007/01/30
N/A
N/A
SA070154 Varian Medical
Medical - On Board
Board Imager CBCT
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#102042/118351/121457/134481/136591/142538/146675/1511
68/155746)
SA070163
Hemo Cue Ltd - HemoCue Glucose 201 and HemoCue Glucose
201RT instruments
MHRA
2007/001/015/081/014
Action
2007/01/30
2543 7442
SA070164
Siemens Diagnostics - IMMULITE 2000/2005 Chartable Report
Used with SMS
MHRA
2007/001/023/601/530
Action
2007/01/31
Siemens Ltd.
2870 7533
79
Monthly Summary of Medical Device Safety Alerts - December 2006
MDCO Ref. No.
Source of Information*
Date of Issue
(YYYY/MM/DD)
SA061201
SA061202
SA061203
SA061204
SA061205
SA061206
SA061207
SA061208
SA061209
SA061210
SA061211
SA061212
SA061213
SA061214
SA061215
SA061216
SA061217
SA061218
SA061219
SA061220
SA061221
SA061222
SA061223
SA061224
SA061225
SA061226
SA061227
SA061228
SA061229
SA061230
SA061231
SA061232
SA061233
SA061234
SA061235
BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human CD16
Monoclonal Antibody, Clone 3G8, Cat. No. 555403, lot # 43033
BD Pharmingen PE-Conjugated Mouse Anti-Human Fetal Hemoglobin
Monoclonal Antibody, Clone 2D12, Cat. No. 551797, lot # 38377
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
#DS300
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
versions
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
Abbott
Inc. RealTime CT/NG assay and
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 #
TSX-101A
Philips Brilliance CT Big Bore System, Lot or Serial # 7062 and 7017
Becton Dickinson Asia Ltd.
Agent Contact
Telephone No.
Remarks
2006/12/04
2575 8668
The local agent informed that no affected units had
been distributed in Hong Kong.
2006/12/04
2575 8668
The local agent informed all affected users.
MHRA
2006/011/030/291/010
FSCA
2006/12/04
2807 8556
MHRA
2006/011/022/081/001
FSCA
2006/12/04
Johnson & Johnson Medical
Hong Kong
2006/12/06
Boston Scientific H. K. Ltd.
2960 7117
Data Innovations Asia
2398 3182
FDA
Z-0212-2007 to Z-0214-2007
Class II
2006/12/06
FDA
Z-0218-2007
Class II
2006/12/06
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
2006/12/06
2738 2818
FDA
Z-0230-2007 to Z-0232-2007
Class II
MHRA
MDA/2006/067
Action
2006/12/06
MHRA
2006/011/030/601/437
FSCA
2006/12/06
2806 4841
e local
agent informed that
The
Th
local agent
that no affected units
units had
had
MHRA
MHRA
2006/011/015/291/006
2006/012/007/081/004
FSCA
FSCA
2006/12/06
2006/12/08
Interdental Ltd.
2541 1096
MHRA
2006/012/005/601/444
FSCA
2006/12/08
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
2006/12/11
Recall # 32953
Type II
2006/12/11
2789 3300
2006/12/11
2919 1362
2006/012/007/601/454
Z-0228-2007
Z-0244-2007
FSCA
Class II
Class II
2006/12/11
2006/12/13
2006/12/13
2806 4841
Z-0247-2007
Class II
2006/12/13
Dade Behring Hong Kong Ltd
2803 0118
Z-0248-2007 / Z-0249-2007
Class II
2006/12/13
Arjo Far East Limited
2508 9553
2006/12/13
2960 7117
FSCA
2006/12/13
2418 9698
Conmed Soft Tip Frazier, Frazier Surgical Suction Instrument and
Health Canada
Poole Suction Instrument
Philips Ultrasound IE33 Diagnostic Ultrasound Transducer, Identifier
Health Canada
S12-4
Philips Medical Systems Gemini GXL 6/10/16 Slice Pet/CT System, lot
Health Canada
or serial # 882410
Medi-Inn Swabette, model or catalog # MIS300 and MIS401
Health Canada
LifeScan OneTouch Ultrasmart Blood Glucose Meter, model or catalog
# 020-720 and 020-721 with serial numbers starting with TC, TD, TF or
LifeScan Ltd.
TG
Unomedical A/S Cord Clamp Clipper, Serial # M3186023572, Lot #
Health Canada
125900
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
system, model 7900
Abbott Diagnostics Architect LH Reagent
MHRA
Accumetrics Inc. Verify Now P2Y12 Assay Device Kit, Part No. 85054
FDA
Teleflex Medical Neoprene Pecan Shaped Breathing Bag
FDA
Dade Behring Brand MicroScan Prompt Inoculation System-D; Catalog
FDA
#B1026-10D
Arjo Inc. Sling Rope/Connector Asembly Kits
FDA
Boston Scientific 1cm peripheral cutting balloon microsurgical dilatation
devices
Fisher and Paykel Healthcare Ltd (NZ) Acclaim HC401 Nasal Mask
MHRA
Local Agent
2006/011/023/081/004
80
Sanko Medical Systems (H.K.)
Ltd.
Philips Electronics Hong Kong
Ltd.
Medisource Supply (Asia) Co.
Ltd.
Ltd.
Ltd.
2384 0688
2821 5480
2145 4442
2876 7525
2821 5480
Hong Kong
2738 6080
Sanko Medical Systems (H.K.)
Ltd.
2384 0688
The Government of the HKSAR
Fisher and Paykel Healthcare Ltd (NZ) All Single Use Heated Breathing
Circuits
Arcomed Administration Set-3101-LPPJ
Boston Scientific Hemashield vascular grafts and fabrics
MHRA
2006/012/013/291/005
FSCA
2006/12/13
2418 9698
SA061237
SA061238
MHRA
2006/012/012/601/458
FSCA
2006/12/14
2006/12/15
2960 7117
SA061239
Boston Scientific Katzen infusion wires
2006/12/15
2960 7117
SA061236
SA061241
SA061242
William Cook Europe Flexor Check-Flo Micropuncture Radial Artery
Access Introducer Sets with AQ Hydrophilic Coating
Lombard Medical - Bifurcated Endovascular Graft Aorfix II
Inditherm Heating Mattress
SA061243
Boston Scientific Mach 1 guide catheters
SA061244
Medtronic Rocker Reducer instruments
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
SA061240
SA061249
MHRA
MDA/2006/071
Action
2006/12/18
MHRA
MHRA
2006/012/014/081/002
2006/011/024/401/010
FSCA
FSCA
2006/12/15
2006/12/18
2006/12/19
2960 7117
2006/12/19
2919 1362
FSCA
2006/12/18
2006/012/007/081/002
FSCA
2006/12/18
Guidant Hong Kong Ltd.
2593 2235
MHRA
2006/012/018/291/025
FSCA
2006/12/19
2006/12/20
2919 1362
MHRA
2006/002/015/291/004
FSCA
2006/12/20
2317 0988
FDA
Z-0206-2007 / Z-0207-2007
Class I
2006/12/20
Hong Kong
2738 2818
SA061250
LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips
SA061251
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses
FDA
Z-0148-2007
Class II
2006/12/20
AMO Asia Ltd.
2401 5861
SA061252
Terumo Cardiovascular Systems Terumo Perfusion System
BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached
Multiple Sample Adapter Sterile
FDA
Z-0233-2007 to Z-0242-2007
Class II
2006/12/20
2866 0811
FDA
Z-0253-2007
Class II
2006/12/20
2575 8668
SA061254
AMO PhacoFlex II Model SI40NB Intraocular Lenses
FDA
Z-0267-2007
Class II
2006/12/20
AMO Asia Ltd.
2401 5861
SA061255
Medl
dliine Industries Medl
dliine Premium Wet Sh
Shiin Prep Tray
FDA
Z-02
0268
68-2007
2007
Class
Cl
II
2006/12/20
SA061256
Gambro Lundia AB (Monitor Division) CWP100
MHRA
2006/008/017/081/001
FSCA
2006/12/20
Gambro China Ltd.
2576 2688
SA061257
Biodiagnostics Ltd. Crithidia Luciliae Slides - Catalogue no. L058 / L108
MHRA
2006/012/004/601/443
FSCA
2006/12/21
SA061258
Roche Diagnostics Cobas Taqman CT test, Amplicor Chlamydia
Trachomatis Detection Kit, Amplicor Chlamydia
MHRA
2006/011/024/081/004
FSCA
2006/12/21
Limited
2485 7555
SA061259
Invacare Spectra Plus Powered Wheelchair
MHRA
2004/011/004/151/010
FSCA
2006/12/21
Direct Health Ltd.
2528 1109
SA061260
Boston Scientific Wallstent endoscopic biliary endoprosthesis with
Unistep Plus delivery system
2006/12/22
2960 7117
SA061253
SA061261
B Braun Aesculap Metha Modular short Stem Prosthesis
SA061262
BD Mini Blade
MHRA
SA061263
FDA
SA061264
2006/011/023/081/010
FSCA
2006/12/21
2006/12/28
B. Braun Medical (Hong Kong)
Ltd.
Hong Kong
Hong Kong
2277 6125
2575 8668
2738 2818
2738 2818
Z-0261-2007 & Z-0262-2007
Class I
2006/12/27
FDA
Z-0263-2007
Class I
2006/12/27
FDA
Z-0258-2007 & Z0259-2007
Class II
2006/12/27
Ultronics Enterprise Ltd.
2764 5208
FDA
Z-0269-2007
Class II
2006/12/27
2960 7117
FDA
Z-0270-2007 to Z-0287-2007
Class II
2006/12/27
FDA
Z-0288-2007
Class II
2006/12/27
FDA
Z-0302-2007
Class II
2006/12/27
2877 3077
2006/12/27
GE Medical Systems Hong Kong
Ltd.
2783 1838
Health Canada
Recall # 33044
Type II
2006/12/27
2272 8922
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
Health Canada
Recall # 33048
Type II
2006/12/27
2593 2235
SA061277
GE OEC Medical System, DBA GE Healthcare OEC 9900
Health Canada
Recall # 33053
Type III
2006/12/27
Guidant Hong Kong Ltd.
Ltd.
SA061265
SA061266
SA061267
SA061268
SA061269
SA061270
SA061271
SA061272
SA061273
SA061274
SA061275
FDA
Z-0291-2007
Class II
FDA
Z-0294-2007
Class II
2006/12/27
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
2393 9511
2393 9511
81
2783 1838
SA061278
Siemens Medical Solutions Linear Accelerators
Health Canada
Recall # 33065
Type III
2006/12/27
Siemens Ltd.
2870 7533
SA061279
Siemens AG Lithoskop
Health Canada
Recall # 33214
Type III
2006/12/27
2870 7533
SA061280
Bausch & Lomb 20 Gauge High Speed Electric Vitrectomy Cutters
MHRA
2006/012/015/081/007
FSCA
2006/12/28
Siemens Ltd.
Bausch & Lomb (Hong Kong)
Ltd.
SA061281
SuperDimension Bronchus System
MHRA
2006/012/008/081/012
FSCA
2006/12/28
82
2213 3179
83
84
85
Monthly Summary of Medical Device Safety Alerts - November 2006
MDCO Ref.
Source of
Reference No. by Source Alert Type by Source Date of Issue
Local Agent
No.
Information*
(YYYY/MM/DD
)
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
8881
3 44 FH Telemetry System, Software versions v3.8
GE ApexPro
SA060333
FDA
Z-0054-2007
Class II Recall
2006/11/01
and earlier
Ltd.
Depuy PFC Oval Dome Patella, Part Number 960100, Lot:
SA060334
FDA
Z-0057-2007
Class II Recall
2006/11/01
2203528
Kong
Cardinal Health Cardiovascular Split Drape II, various models
Z-0058-2007 to Z-0062-2007
Class II Recall
2006/11/01
FDA
N/A
SA060335
and lot numbers
Siemens Medical Solutions Sienet Cosmos V15C, model
SA060336 number 10018969, Serial numbers 1001, 1010, 1011, 1028,
d 1029Medical Solutions Syngo Imaging, Sienet Sky and
Siemens
SA060337 Sienet Magic View 300 picture archiving and communications
FDA
Z-0069-2007
Class II Recall
2006/11/01
FDA
Z-0070-2007 to Z-0072-2007
Class II Recall
2006/11/01
Siemens Ltd.
Siemens Ltd.
Agent Contact
Telephone No.
2574 3251
2783 1838
2738 6080
FDA
Z-0080-2007
Class II Recall
2006/11/01
Radiometer America Radiance Data Management System,
SA060339 Software Version 2.60, modification for the ABL800 Flex Blood
Gas Analyzer, Catalog Numbers: 914-418 and 914-426
FDA
Z-0115-2007
Class II Recall
2006/11/01
N/A
N/A
MHRA
2006/010/010/291/005
2006/11/01
Siemens Ltd.
2870 7533
SA060341 Ferno Falcon Six stretcher trolleys
SA060342
Boston Scientific Mach 1 Peripheral Guide Catheter, lot #
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
FDA
Z-0078-2007
FDA
Z-0116-2007
Respironics, Inc.
N/A
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)
(1) 2781 0232; (2) 2541 The local agents informed that no affected units had been
1041
distributed in Hong Kong.
2006/11/01
N/A
N/A
2006/11/03
2960 7117
N/A
N/A
2806 4201
2006/11/08
N/A
N/A
Class II Recall
2006/11/08
N/A
N/A
Class II Recall
2006/11/08
N/A
N/A
Urgent Medical Device
Recall
2006/11/09
2268 9229
With affected units in Hong Kong.
2006/11/09
2575 8668
The local agent informed that no affected units had been
Action
Action
2006/011/001/081/010
SA060349 Getinge steam sterilizers, various models
MHRA
2006/009/004/081/008
2006/11/09
N/A
N/A
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
2384 0688
SA060352 Toshiba Medical Systems Aquillion 16-Slice System
Health Canada
32639
Type II Recall
2006/11/13
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
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 manufacturer informed that no affected units had been
2006/11/08
MHRA
SA060354
2006/11/06
SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745)
Endologix Visiflex bifurcated Delivery Catheters, 155mm, used
SA060350 for the Powerlink System (models 25-16-155BL and 28-161 BL)
2870 7533
(1) Cook Asia (Hong Kong) Ltd.;
(2) A.R. Burkhill & Sons (Hong
Kong) Ltd.
Action
Action
Recall
Action
Action
Action
N/A
2870 7533
Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot
SA060338
1722922
SA060340 Siemens MODULARIS Uro endourology tables
Remarks
86
SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine
Health Canada
32451
Type II Recall
2006/11/13
2877 3077
SA060358 Toshiba Medical Systems Opart MRI System
Health Canada
32523
Type II Recall
2006/11/13
2384 0688
2838 8423
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
Health Canada
32531
Type II Recall
2006/11/13
Uninet Technology Ltd.
Health Canada
32280
Type II Recall
2006/11/13
MHRA
2006/011/010/291/002
2006/11/13
2240 6260
MHRA
2006/011/009/081/009
2006/11/14
2317 0988
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
Action
Action
2645 8703
FDA
Z-0130-2007 to Z-0144-2007
Class II Recall
2006/11/15
Kong
2738 6080
FDA
Z-0151-2007
Class II Recall
2006/11/15
HealthCare Diagnostics Ltd.
2563 5193
FDA
Z-0152-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0153-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0154-2007 & Z-0155-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0156-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0159-2007
Class II Recall
2006/11/15
2393 9511
FDA
Z-0160-2007
Class II Recall
2006/11/15
Kong) Ltd.
FDA
Z-0163-2007 & Z-0164-2007
Class II Recall
2006/11/15
N/A
N/A
Becton Dickinson and
Company (Japan)
N/A
Voluntary Recall
2006/11/15
2575 8668
The local agent confirmed having no record of importing the
affected devices into Hong Kong.
MHRA
2006/011/014/291/014
2006/11/15
2240 6260
SA060375 Draeger Medical Infant Warmer - RW82VHA-1C
MHRA
2005/005/025/401/001
2006/11/15
2877 3077
SA060376 Novagen Ltd 2mm Angled Suction Tip
MHRA
2006/011/010/401/006
2006/11/15
Onwon Trading Limited
2757 7569
SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays
MHRA
2006/011/013/081/007
2006/11/16
N/A
N/A
2006/11/17
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
2574 3251
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
b
Hitachi
Medical Systems Echelon Magnetic Resonance
SA060367
Imaging 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
SA060372
Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number
W2243511
USA Instruments 1.5T HD Head Neck Spine Array (Model
SA060373 2416329, for GE 1.5T Excite MR System) and 3.0T HD Head
Neck Spine Array (Model 2415545, for GE 3.0T Excite MR
S
)
SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129
SA060374
Beckman Coulter Access Immunoassay Systems Thyroglobulin
Antibody
Medtronic SynchroMed® and IsoMed® Implantable Pain
SA060378
Infusion Pumps, various models
SA060379 Ferno Restraining straps/harness-Pedi-Mate 678
Owen Mumford Unistik 3 Neonatal &
Laboratory/Confort/Normal
Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine
SA060381
Therapy-LPD24
SA060380
Medtronic
International, Ltd.
N/A
MHRA
2004/012/001/061/029
MHRA
2006/011/013/291/002
MHRA
2006/010/013/601/34
SA060382 Bard Access Systems HemoGlide Catheter Kits
MHRA
2006/008/031/291/002
Tyco Healthcare OptiVantage DH Contrast Media Injection
SA060383
System
MHRA
2006/011/014/081/008
Action
Action
Action
Action
Important Patient Safety
Management Information
Action
Action
Action
Action
Action
87
(1) 2781 0232; (2) 2541 The local agent informed that no affected units had been
1041
Boston Scientific System Drape (IVUS motor drive sterile
plastic cover), lot numbers M846990, M835770 and M844470
Boston Scientific Jagwire High Performance Guidewire (lot #
SA060385 8887513) and Jagwire High Performance Extendable
Guidewire (lot # 8887514)
SA060384
Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE
SA060331 Multi-Purpose Solutions, and COMPLETE MoisturePLUS MultiPurpose Solutions (Starter Kits)
Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus
SA060386 and CoaguChek Softclix single-patient self-testing lancing
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
SA060392
Philips Medical Systems M3001A Multi Measurement Server
(MMS) and M1020B Pulse Oximetry Module Philips FAST
Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used
with the IntelliVue or M3/M4 patient monitor M1002
Sorenson Medical ambIT Ambulatory Infusion Pump
SA060393 Cassettes, REF numbers 220139, 220140, 220266 and
220267, all serial numbers
Eatonform Doc-U-Dose Prescription Management System,
SA060394
Item 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
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
K. Ltd.
N/A
Medical Device
Customer Notification
2006/11/21
2960 7117
K. Ltd.
N/A
Recall
2006/11/21
2960 7117
AMO Asia Limited
N/A
Voluntary Recall
2006/11/22
AMO Asia Limited
2401 5811 and 2401
5812
MHRA
2006/009/012/291/010
Action
2006/11/21
Limited
2485 7555
FDA
Z-0165-2007 & Z-0166-2007
Class II Recall
2006/11/22
2821 5480
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
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
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
Type II Recall
2006/11/27
N/A
N/A
2006/11/27
N/A
N/A
Health Canada
32628
MHRA
2006/007/005/601/166
Action
Action
MHRA
2006/011/024/601/421
2006/11/27
N/A
N/A
Health Canada
32733
Type II Recall
2006/11/27
Elekta Ltd.
2892 4320
MHRA
2006/011/009/291/005
Action
2006/11/28
N/A
N/A
FDA
Z-0117-2007
Class II Recall
2006/11/29
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
88
Click on the Press Release by AMO Asia for details:
AMO's Press Release
SA060409
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial
numbers
SA060410 Access Point Medical Canes, various models
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
Smiths Medical International Monitor Patient-BCI Autocorr
3404
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
FDA
Z-0208-2007
Class II Recall
2006/11/29
2919 1362
FDA
Z-0209-2007
Class II Recall
2006/11/29
branch)
2992 0968
FDA
Z-0210-2007
Class II Recall
2006/11/29
branch)
2992 0968
FDA
Z-0220-2007
Class II Recall
2006/11/29
Konica Minolta Business Solutions
(HK) Ltd.
2565 8181
MHRA
2006/011/017/401/001
2006/11/29
N/A
N/A
MHRA
2006/011/022/291/010
2006/11/29
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
SA060416
Action
Action
Action
Action
89
2006/11/29
N/A
N/A
2006/11/29
2814 4829
1 affected unit in Hong Kong.
Monthly Summary of Medical Device Safety Alerts - October 2006
Source of
MDCO Ref.
Local Agent
Information*
(YYYY/MM/DD
No.
)
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,
Health Canada
32333
Type II Recall
2006/10/02
SA060250 models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 &
SA060251
SA060252
SA060253
SA060254
DNM81 Biopharma
3R
Ondine
Periowave Disinfection System Footswitch,
model or catalog # PW1002 and PW1100, lot or serial number
PW-D06-00001 to PW-D06-00400
Applied Medical Technology Endovive Enteral Feeding Device,
specific lots
Huntleigh birthing beds, Models 35000 and 170000; Hoskins
Birthcare, Models L10 and L05
Baxter Healthcare, Administration Set-Continu Flo Solution
Sets with Check Valve
Agent Contact
Telephone No.
N/A
2425 0926
N/A
2807 8556
Health Canada
32178
Type II Recall
2006/10/02
N/A
N/A
K. Ltd.
N/A
Medical Device Market
Withdrawal
2006/10/03
2960 7117
MHRA
MDA/2006/057
Action
2006/10/03
N/A
N/A
2006/10/03
2807 8556
2006/10/03
2277 6125
Action
Action
MHRA
2006/009/020/291/016
MHRA
2006/009/026/291/011
FDA
Z-1517-06
Class II Recall
2006/10/04
2866 0811
FDA
Z-1524-06
Class II Recall
2006/10/04
N/A
N/A
FDA
Z-1525-06
Class II Recall
2006/10/04
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
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
2806 4841
SA060255 B. Braun Arterial / Venous Blood Line, 7210697
SA060256
SA060257
SA060258
SA060259
SA060260
SA060263
SA060264
SA060265
Terumo Khuri Myocardial PH Monitoring System, Catalog
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
Number 305945 and 305950
Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-1001000000
International Medsurg Connection Allegiance Esmark
Bandages, catalog numbers 24593-043A, 24593-044A, 24593063A and 24593-064A
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.
6 Cardiac ablation system - 25mm & 30mm HIFU
Prorhtym
MHRA
2006/009/029/601/319
Varian Medical
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
SA060266
SA060267
ablation catherter
GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm
SA060270
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
SA060273 GE Precision RX/I System, all units
Action
Action
Action
Correction
Action
Customer Notification
Action
Action
Action
2006/10/04
2006/10/06
2006/10/06
Varian Medical Systems Pacific
Inc.
Ltd.
1 affected unit was distributed in Hong Kong.
2724 2836
2783 1838
2006/10/09
2575 8668
2006/10/10
N/A
N/A
2006/10/11
2806 4841
2006/10/11
N/A
N/A
2783 1838
FDA
Z-0704-06
Class II Recall
2006/10/11
Ltd.
FDA
Z-1301-06 to Z-1303-06
Class II Recall
2006/10/11
Ltd.
2783 1838
FDA
Z-1514-06
Class II Recall
2006/10/11
2645 8703
FDA
Z-1485-06
Class II Recall
2006/10/11
Ltd.
2783 1838
90
Remarks
The local agent informed all the affected users.
FDA
Z-1543-06 to Z-1549-06
Class II Recall
2006/10/11
Evergreen Health Care Ltd.
2893 0694
FDA
Z-0001-07
Class II Recall
2006/10/11
Ltd.
2783 1838
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
FDA
Z-0009-07 to Z-0011-07
Class II Recall
2006/10/11
2645 8703
SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets
MHRA
2006/004/027/601/094
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
N/A
Product Field Action
Notification
2006/10/13
2575 8668
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.
FDA
P06-167
FDA News
2006/10/13
Kong
2735 8262
Updated on 2006/10/23. Please see SA060241 for details.
MHRA
2006/010/003/081/006
Action
2006/10/16
Beijing Since Medical Scientific Co.
Ltd.
9262 1527
Health Canada
32353
Type II Recall
2006/10/16
2575 8668
Health Canada
32288
Type II Recall
2006/10/16
N/A
N/A
Health Canada
32120
Type II Recall
2006/10/16
Gambro China Ltd.
2576 2688
1 affected unit was distributed in Hong Kong.
Health Canada
32374
Type II Recall
2006/10/16
BioMerieux China Limited
2356 7033
Health Canada
32375
Type II Recall
2006/10/16
Beijing Ji Yuan Electronic Co.
(86)10-6202-3856
Health Canada
32310
Type II Recall
2006/10/16
N/A
N/A
2006/10/17
2960 7117
SA060274
SA060275
SA060276
SA060277
SA060278
Pointe Scientific Alcohol reagent sets and control standards,
various models
GE OEC Medical Systems 4 inch Anterior Cervical Post, Part
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
(VAD) Driver
Stryker Navigation Systems with Dell laptop computer model
D800
Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch,
Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II
Oversized Nonporous Fin-Stem Tibial Punch
SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281
Becton Dickinson
Asia Ltd.
St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650
programmers used with certain St. Jude Identity pacemakers
SA060237
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,
SA060236 2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose
Test Strips
AGA Medical Corporation Delivery System Amplatzer TorqVue
SA060281
Delivery and Exchange Systems
g
BD Procount Progenitor
Cell Enumeration,, Part No. 340498,,
SA060282
Lot No. 45602
Walter Lorenz Surgical Lactosorb Suspension Screw, model or
SA060283
catalog # 915-2335, lot or serial # 753200
SA060284 Teraklin AG Mars Treatment Kit
SA060285
SA060286
SA060287
SA060288
SA060289
SA060290
SA060291
Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot
or serial # 50417
Michigan Instruments Thumper Mechanical CPR Device,
model or catalog # 1007
Randox Laboratories Fructosamine Control Level 1, lot or serial
# 239FR
Boston Scientific Interlock Detachable Coils For Occlusion, lot
number 6628239
Boston Scientific Renegade 18 Microcatheter, lot number
7513978
Boston Scientific Stainless Steel Greenfield Vena Cava Filter,
lot number 7826572
Advanced Bionics Linear Family Leads (product numbers SC2108, SC-2138, SC-2148 series)
K. Ltd.
K. Ltd.
K. Ltd.
N/A
N/A
N/A
Recall
Recall
Recall
2006/10/17
2960 7117
2006/10/17
2960 7117
The local agent
g
informed that no affected units had been
3 affected units were distributed in Hong Kong.
Advanced Bionics
N/A
Important Notification
2006/10/17
2960 7117
MHRA
2006/010/013/601/347
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
SA060296 sampling blood for oxygen levels and measuring pressures in
the right heart
FDA
Z-0030-2007
Class II Recall
2006/10/18
N/A
N/A
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
SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0
Thoratec brand Sealed Arterial Cannula for use with the
SA060293
Thoratec Ventricular Assist Device System
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use
SA060294 in STERRAD 100, STERRAD 100S and STERRAD 50
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
V 0J Double-Lumen Balloon Wedge Pressure Catheter, for
Arrow
91
SA060299 Roche Diagnostics CoaguChek PT test strips
SA060239 Sunrise Medical Jay J2, Wheelchair back
Medtronic SynchroMed EL Programmable Infusion Pumps,
SA060240
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
SA060312
SA060313
SA060314
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 89SG#-45,
45, Lot number S296
S2964090
4090
0120, Item Number SG#
Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5
mL. Product Code: E0100 under Hospira's label, Syrex, Lot:
22 010 9D Doc-U-Dose Prescription Management System,
Eatonform
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
FDA
N/A
Press Release
2006/10/19
Limited
2485 7555
MHRA
MDA/2006/060
Action
2006/10/19
N/A
N/A
FDA
Z-0022-0007
Class I Recall
2006/10/20
2919 1362
2006/10/20
2919 1362
2006/10/23
2376 1805
2006/10/23
Kong
2735 8262
Medtronic
International, Ltd.
N/A
MHRA
2006/007/027/291/001
FDA
P06-174
FDA
Z-0026-2007
Class II Recall
2006/10/25
N/A
N/A
Z-0034-2007
Class II Recall
2006/10/25
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
2783 1838
FDA
Z-0043-2007
Class II Recall
2006/10/25
Ltd.
Ltd.
Kong
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
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
2919 1362
FDA
Z-0052-2007 & Z-00532007
Class II Recall
2006/10/25
FDA
Z-0055-2007
Class II Recall
2006/10/25
N/A
N/A
2006/10/25
Siemens Ltd.
2870 7533
Recall
2006/10/25
2268 9229
32430
Type I Recall
2006/10/30
N/A
N/A
32469
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32449
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32484
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32311
Type II Recall
2006/10/30
Ltd.
2783 1838
2006/010/020/081/015
Respironics, Inc.
N/A
Health Canada
Health Canada
Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr,
Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed
SA060318
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 SA060320
Microbiology Module, Version 7.4
SA060319
2783 1838
N/A
MHRA
SA060244
9262 1527
N/A
2006/070/019/601/356
SA060243
2738 6080
2006/10/25
2006/010/004/401/021
MHRA
SA060327
Action
Action
Action
Ltd.
Ltd.
2783 1838
Update to SA060236. For enquiry, please contact the local
agent.
According to FDA, distribution of affected units was limited to
the United States only. Pending the manufacturer's
confirmation.
2006/10/25
MHRA
SA060316 Southern Scientific Autotilt ultrasound couches
SA060317
FDA News
FDA
SA060315 Omega truCATH catheters (TCH-10)
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
Voluntary Field
Corrective Action
Action
Supersedes the MDA/2006/056 (Ref: SA060163). The
manufacturer informed that no affected units had been
92
Smith & Nephew Legion Offset Coupler Trials, Model or
Catalog # 71434301, 71434302, 71434304 and 71434306
Micrus Endovascular Guidewire Insertion Device, Lot or Serial
SA060322
# F22741, F22743 and F22744
SA060321
SA060245
LifeScan OneTouch SureStep Test Strips, Lot or serial #
2631383
SA060323
ConMed Detacha Tip Multi-Use Laparoscopic Instruments and
Disposable Hand Held Graspers and Dissectors
Health Canada
32286
Type II Recall
2006/10/30
2645 8703
Health Canada
32512
Type II Recall
2006/10/30
N/A
N/A
Health Canada
32428
Type II Recall
2006/10/30
Kong
2735 8262
MHRA
2006/010/025/081/009
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
2240 6260
N/A
N/A
N/A
N/A
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
Beijing Health
Inspection Website
N/A
Action
Action
Action
Action
Public Annoucement
2006/10/31
93
N/A
N/A
Alcon Hong Kong Ltd.
2161 0888
Extension of the recall case # SA060238. The local agent
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.
Monthly Summary of Medical Device Safety Alerts - September 2006
MDCO Ref.
Source of
Local Agent
No.
Information*
(YYYY/MM/DD
)
Gantry Direct Drive systems in Varian High Energy Clinac
Varian Medical
SA060167
N/A
2006/09/01
linear accelerators
Correction
Inc.
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 # 82Johnson & Johnson Medical Hong
SA060169
Health Canada
32097
Type II Recall
2006/09/04
1731, lot or serial # CGHBGC and CGHBGD
Kong
Smith & Nephew Hewson Suture Retrievers Item 7111-1579,
SA060170
Health Canada
32117
Type II Recall
2006/09/04
lot or serial # 05HSM0014
Mentor Clear Advantage With Aloe MECs, model or catalog #
26-06100, 26-06200, 26-06300, 26-06400 & 26-06500
Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60
SA060172
System and Vitek 2 System
SA060171
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
SA060183
SA060184
SA060185
SA060186
BD Unopette System Tests for Erythrocyte Fragility Test Kit,
catalog # 365830
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry
Systems, Automated Clinical Chemistry Analyzer - human
serum, plasma and urine tests
Pointe Scientific AutoHDL Cholesterol Reagent Sets, various
models
Bayer Healthcare RapidLab 1200 Systems, models 1245 and
1265 - blood gases, electrolyte and blood pH test systems
2006/09/04
N/A
N/A
Health Canada
31891
Type II Recall
2006/09/04
2356 7033
Health Canada
32191
Type II Recall
2006/09/04
Direct Health Ltd.
2528 1109
2006/09/05
2960 7117
2006/09/05
2807 8556
2006/09/05
N/A
N/A
3 affected units were distributed in Hong Kong.
N/A
MHRA
2006/008/031/081/004
MHRA
2006/008/029/291/003
MHRA
2006/009/004/291/014
Action
2006/09/06
2803 0118
FDA
Z-1437-06
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
2575 8668
FDA
Z-1448-06 to Z-1450-06
Class II Recall
2006/09/06
2814 4829
FDA
Z-1454-06 to Z-1459-06
Class II Recall
2006/09/06
2893 0694
Class II Recall
2006/09/06
2814 4829
2006/09/06
N/A
N/A
2006/09/06
Siemens Ltd.
2870 7533
2 affected units in Hong Kong.
2006/09/07
Kong
2738 6080
2006/09/08
2960 7117
2006/09/08
N/A
N/A
2006/09/08
Limited
2485 7555
2006/09/08
N/A
N/A
2006/006/014/601/150
SA060188 Siemens Medical Solutions Siregraph CF
MHRA
2006/008/015/121/001
MHRA
2006/008/021/081/006
K. Ltd.
N/A
MHRA
2006/008/010/401/007
Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010
SA060192
system
MHRA
2006/008/024/081/004
SA060193 Sorin Group S5 Heart Lung Machine
MHRA
2006/008/003/401/007
Recall
Action
Action
K. Ltd.
Z-1464-06 & Z-1465-06
2645 8703
Type II Recall
FDA
SA060191 Penlon Sigma Delta Sevoflurane Vaporizer
2738 6080
32095
MHRA
SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System
2724 2836
Remarks
2992 0968
Health Canada
SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella
Codman CSF External Drainage System III, 82-1731(EDS III
SA060189 without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5,
CGGCT8, CGGCT9
Agent Contact
Telephone No.
Action
Action
Action
Recall
Action
Action
Action
94
SA060194 Intavent Orthofix Laryngeal mask airway
Respironics NICO model 7300 Cardiopulmonary Management
SA060195
System - serial numbers beginning with 138Applied Medical Technology Endovive Enteral Feeding Device,
SA060196
lot/batch number 6040734
SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867
Radiometer America D826 Accessory kit for single tcpO2
SA060198 Electrodes for use with the TCM400 Transcutaneous Monitor
(Cutaneous Oxygen Monitor) Part Number: 904-308
Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems
SA060199
Femoral Stem and Body, various sizes
SA060200 AGA Medical Amplatzer VSD Occluder
SA060159
SA060160
SA060201
SA060202
SA060203
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
SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000
GE OEC Medical Systems OEC Mini 6800 CC-ARM
ARM, various lot
SA060205
or serial numbers
SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters
BD Vacutainer Blood Collection Assembly with BD Blunt Plastic
SA060206
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)
MHRA
Celki Medical
Company
K. Ltd.
K. Ltd.
2006/009/004/291/003
N/A
N/A
N/A
Action
Important Medical
Device Recall
ifi i Device
UrgentNMedical
Recall
Recall
2006/09/08
N/A
N/A
2006/09/09
2268 9258
2006/09/12
2960 7117
2006/09/12
2960 7117
N/A
N/A
FDA
Z-1436-06
Class II Recall
2006/09/13
FDA
Z-1467-06 to Z-1480-06
Class II Recall
2006/09/13
MHRA
2006/007/017/291/008
Action
2006/09/14
Health Canada
32208
Type I Recall
2006/09/18
Stryker Hong Kong
2518 6915
Health Canada
32272
Type I Recall
2006/09/18
Co. Ltd.
2666 1942
Health Canada
32198
Type II Recall
2006/09/18
2877 3077
Health Canada
32241
Type II Recall
2006/09/18
2807 8556
Health Canada
32257
Type II Recall
2006/09/18
N/A
N/A
Health Canada
32134
Type II Recall
2006/09/18
Agfa Hong Kong Ltd.
2873 9336
branch)
Ltd.
Ltd.
Kong
2992 0968
9262 1527
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
2575 8668
FDA
Z-1487-06
Class II Recall
2006/09/20
2876 7525
FDA
Z-1496-06 & Z-1497-06
Class II Recall
2006/09/20
N/A
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
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
Action
2006/09/22
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
2645 8703
2006/09/25
Kong
2738 2818
2006/09/26
2960 7117
2006/09/26
N/A
N/A
2006/09/27
Ltd.
2783 1838
SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector
GE Precision 500D Radiographic and Fluoroscopic Imaging
SA060219
System, all serial numbers
MHRA
2006/009/022/291/010
N/A
MHRA
2006/009/011/601/207
FDA
Z-1304-06
Class II Recall
95
2774 8339
N/A
N/A
(1) 2425 0926; (2) 2332 15 affected units in Hong Kong. Rectification programme
4455
completed.
SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700
K. Ltd.
The local agent will inform all the future users about the
concerned issue.
N/A
SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves
Biosense Webster Europe RefStart Catheter with QwikPatch
SA060216
External Reference Patch
Boston Scientific Flexima all purpose drainage catheters, lot
SA060217
number 8955327
2783 1838
Action
Action
Action
Action
Action
Recall
Action
2 affected units in Hong Kong. Rectification programme has
been completed.
SA060220
BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and
240953
SA060221 Conmed System 2500 and 5000 Electrosurgical Units
SA060222
Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual
wheelchairs
SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500
SA060224
SA060225
SA060226
SA060227
SA060228
SA060229
SA060230
SA060231
Kerr Optibond Solo Plus Self-Etch Adhesive System, Part
Number 31966
Beckman Coulter LH700 series Hematology Analyzers 2B3
2B4 and 2B5 Software
GE Healthcare Technologies Gas absorbers Compact
Absorber 427002000
Smiths Medical Chest Drain - Portex Chest Drainage System
with Adjustable Straw - 2000ml
Boston Scientific Vaxcel Implantable Chest Ports with PASV
Valve Technology, specific lots
BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot #
6152968 and BD Procount (IVD), lot # 340398
Abbott Laboratories FSH calibrator and AsSY Master calibrator
batches
Abbott Laboratories CELL-DYN Sapphire List Number 08H0001
SA060163 Sunrise Medical Jay J2, Wheelchair back
CryoCath Arctic Circler Curvilinear Cardiac Cryoablation
SA060164 Catheters
Catheters,, catalog nos.
nos. 2AC20,
2AC20, 2AC22,
2AC22, 2AC24,
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
SA060233 Micrus Endovascular Watusi Guide Wire System
SA060234
Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245,
LI146, LI163
SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J
LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008)
SA060238 and OneTouch SureStep (part #020-052, lot #2627353) Blood
Glucose Test Strips
FDA
Z-1505-06
Class II Recall
2006/09/27
2575 8668
FDA
Z-1507-06 & Z-1508-06
Class II Recall
2006/09/27
N/A
N/A
FDA
Z-1509-06 to Z-1511-06
Class II Recall
2006/09/27
Direct Health Ltd.
2528 1109
FDA
Z-1513-06
Class II Recall
2006/09/27
Stryker Hong Kong
2518 6915
Class II Recall
2006/09/27
N/A
N/A
2006/09/27
2240 6260
2006/09/27
Ltd.
2783 1838
2006/09/27
2317 0988
2006/09/28
2960 7117
FDA
Z-1521-06
MHRA
2006/009/022/291/004
MHRA
2006/009/005/601/267
MHRA
2006/009/025/291/001
K. Ltd.
Becton Dickinson
Asia Ltd.
N/A
N/A
Action
Action
Action
Recall
Worldwide Medical
Device Recall
Action
Action
2006/09/28
2575 8668
2006/09/28
2806 4841
2006/09/28
2806 4841
MHRA
2006/009/027/601/314
MHRA
2006/008/025/601/253
MHRA
MDA/2006/056
Action
2006/09/28
N/A
N/A
N/A
Market Withdrawal
2006/09/28
Pacific Medical (HK) Ltd.
2343 8009
2006/09/28
AMO Asia Limited
2401 5861
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
Kong
2735 8262
CryoCath
Technologies, Inc.
Advanced Medical
Optics, Inc.
N/A
MHRA
2006/009/019/181/006
MHRA
2006/009/019/181/004
MHRA
2006/009/004/291/006
MHRA
2006/009/025/401/010
LifeScan Inc.
N/A
Voluntary Limited Market
Recall
Action
Action
Action
Action
Press Release
96
Superseded by MDA/2006/060.
Monthly Summary of Medical Device Safety Alerts - August 2006
MDCO Ref.
Source of
Local Agent
No.
Information*
(YYYY/MM/DD
)
2006/007/027/291/016
N/A
SA060070 Biotronik - Stratos LV-T Pacemaker
MHRA
2006/08/01
Action
Dade Behring N Rheumatology Standard SL for RF, N/T
SA060071
MHRA
2006/006/026/131/002
2006/08/01
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
364896 and Vacutainer Luer adaptor product code 367300
SA060073 AFOS Ltd. Endoscope storage facility (ESF)
SCC Soft Computer SoftPath ASXII Software Releases 2.3.0
and 4.3.7
SCC Soft Computer SoftPath ASCII Software, Releases 1.2,
SA060075
2.1, and 2.3
Brainlab ExacTrac Robotics for installation on the Varian Exact
SA060076 Couch, a component of the Novalis Shaped Beam Surgery
St. Francis Medical Technologies brand X STOP® Interspinous
S
SA060077
Process Decompression (IPD) System
Radiometer America Waste tubing, Model # 842-326 (pump
SA060078
tube for waste) and Model # 842-327 (pump tube for solution)
SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120
SA060074
Radiometer America Radiance Data Management System
SA060080 Software Version 2.42 (Stand-alone software package) for the
Radiance STAT Analyzer Management System
Microcuff Pediatric and Adult Endotracheal Tubes, various
SA060081
sizes
Terumo Advanced Perfusion System 4 inch diameter Roller
SA060082 Pump (model 801040) and 1 Large Roller Pump (model
801041)
Varian
Medical Systems Gamma Win software, part number
SA060083
GM11019110, versions up to and including 1.62
Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
SA060084
various sizes
LifeCell Repliform Tissue Regeneration Matrix, catalog
SA060085
numbers 820241, 820245 and 820246
Action
2006/08/02
N/A
N/A
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
FDA
Z-1261-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1262-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1263-06 to Z-1265-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1266-06 & Z-1267-06
Class II Recall
2006/08/02
2866 0811
FDA
Z-1268-06 to Z-1270-06
Class II Recall
2006/08/02
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
MHRA
2006/007/031/081/009
Health Canada
30936
Type II Recall
Health Canada
31533
Type II Recall
Health Canada
31863
Type II Recall
Health Canada
31920
Type II Recall
Health Canada
31981
Health Canada
Health Canada
SA060092
SA060093
SA060094
SA060065
SA060066
SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent
2575 8668
MDA/2006/044
Z-1271-06 to Z-1285-06
SA060091
2803 0118
FDA
FDA
SA060090
N/A
MHRA
K. Ltd.
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
Agent Contact
Telephone No.
MHRA
Recall
Action
Action
Action
Action
Inc.
branch)
2724 2836
2992 0968
Remarks
The manufacturer informed all the affected users.
2006/08/03
2960 7117
2006/08/03
N/A
N/A
2006/08/03
Bio-Gene Technology Ltd.
2646 6101
2006/08/03
2806 4841
2006/08/04
N/A
N/A
2006/08/07
N/A
N/A
2006/08/07
N/A
N/A
2006/08/07
Ultronics Enterprise Ltd.
2764 5208
2006/08/07
Ltd.
2783 1838
Type II Recall
2006/08/07
N/A
N/A
31344
Type I Recall
2006/08/07
N/A
N/A
31892
Type I Recall
2006/08/07
3157 7244
2006/007/013/291/005
Action
2006/08/07
Limited
2485 7555
97
SA060096 Smiths Medical International-Custom Epidural Pack
MHRA
2006/007/031/081/001
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
FDA
Z-1305-06
FDA
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,
U 11 U 12
DeSoutter Medical, Sagittal Blade-Opposed Tooth
SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus
SA060108
Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code:
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
2317 0988
2807 8556
Action
2006/08/09
N/A
N/A
Class II Recall
2006/08/09
N/A
N/A
Z-1315-06
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
2006/007/010/291/001
CryoCath
Technologies Ltd.
N/A
Action
MHRA
2006/008/002/601/194
MHRA
2006/008/004/081/002
MHRA
2006/003/001/261/001
MHRA
2006/007/012/291/005
Celki Medical
Company
N/A
MHRA
2006/007/031/081/014
K. Ltd.
N/A
Action
Action
Action
Action
Urgent Field Action
Notification
Action
Recall
Action
2006/08/11
N/A
N/A
2006/08/11
N/A
N/A
2006/08/14
2268 9228
2006/08/14
Gambro China Ltd.
2576 2688
2006/08/16
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
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
2006/08/16
branch)
2992 0968
2006/08/17
N/A
N/A
2006/08/18
N/A
N/A
2006/08/21
Limited
2485 7510
FDA
Z-1335-06 to Z-1351-06
2005/005/006/401/010
2006/007/010/291/007
2919 1362
MHRA
Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or
Catalog # 32536, lot or serial # 032AY1 & 139AY1
2006/08/07
MHRA
SA060068 Gambro Prismaflex Continuous Renal Replacement System
2317 0988
SA060122 Medicina Infant Feeding Tubes
SA060123
2006/08/07
Action
MHRA
2006/08/07
2006/08/09
SA060121 Edwards Lifesciences Aquarius Heamofiltration machine
Roche Diagnostics Accu-chek Advantage for Accudata GTS,
SA060067
Accu-Soft & Accu-Chek Advantage Blood Glucose Meters
Action
Action
Action
Action
Health Canada
31495
Class II Recall
Action
Action
Type I Recall
Health Canada
31616
Type I Recall
2006/08/21
Gambro China Ltd.
2576 2688
Health Canada
32029
Type I Recall
2006/08/21
2789 3300
98
For further details, please see the website notice:
http://www.mdco.gov.hk/english/recalls/recalls_20060828.ht
l
Health Canada
31805
Type II Recall
2006/08/21
2240 6260
Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery
Systems, Hemodialysis Machine 1550, Machine 1550 Single
SA060125
Needle Hemodialysis and System 1000 Dialysate Delivery
System, all serial numbers
Health Canada
32017
Type II Recall
2006/08/21
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
2317 0988
Health Canada
31890
Type II Recall
2006/08/21
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
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
2393 9511
SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers
Health Canada
32059
Type II Recall
2006/08/21
Gambro China Ltd.
2576 2688
Siemens Ltd.
2870 7533
2006/08/21
2240 6260
2006/08/21
2814 4829
SA060124
SA060128
SA060129
SA060130
SA060131
SA060132
SA060133
Beckman Coulter FP1000 Cell Preparation System, model or
catalog # 624922
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
Siemens Medical Solutions Oncology Care Systems ZXT
SA060136
Treatment Table,
Table, model or catalog # 9820952 and 05844621
Beckman Coulter Unicel DxI 800 Access Immunoassay System
SA060137
Wash Buffer
Health Canada
32092
Type II Recall
2006/08/21
Action
Action
Action
MHRA
2006/008/016/081/005
MHRA
2006/008/015/121/002
MHRA
2006/008/016/081/012
FDA
Z-1377-06 to Z-1384-06
Class II Recall
2006/08/22
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
MHRA
MDA/2006/046
Immediate Action
2006/08/22
N/A
N/A
SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30
MHRA
2006/008/022/081/011
Action
2006/08/23
2393 9511
FDA
Z-1385-06
Class II Recall
2006/08/23
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
2893 0694
FDA
Z-1398-06 & Z-1399-06
Class II Recall
2006/08/23
Inc.
2724 2836
Class II Recall
2006/08/23
Siemens Ltd.
2870 7533
SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser
Cordis Neurovascular Pre-shaped Prowler and pre-shaped
PROWLER SELECT infusion catheters
Roche Diagnostics Accu-chek Comfort Curve, Advantage,
SA060140
Sensor Comfort and Inform Blood Glucose Meter Test Strips
SA060139
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit,
Catalog No. 1931601
Radiometer America Blood Gas and Co-Ox2 Electrolyte &
SA060144
Metabolyte Analyzers, ABL-700 and ABL-800 Series
Pointe Scientific Alkaline Phosphatase reagents, buffers and
SA060145
substrates, various models
Varian Medical Systems GammaMed software programs for
SA060146 the GammaMed models 12i and 12it radionuclide applicator
SA060143
2006/08/21
Kong
Limited
2738 2818
2485 7510
Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on
SA060147
Varian accelerators with the MLC3PI interface
Baxter Intermate and Infusor Large volume (LV) infusion
SA060148
pumps - all models
Cardinal Health Alaris SE Pump (formerly Signature Edition
SA060149
Infusion Pump), all models
FDA
Z-1401-06
MHRA
MDA/2006/048
Action
2006/08/24
2807 8556
FDA
N/A
Press Release
2006/08/28
The Vita Company Ltd.
2548 7483
SA060150 Chiltern Invadex ceiling track patient hoists with turntables
MHRA
MDA/2006/050
Action
2006/08/29
N/A
N/A
SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups
MHRA
2006/008/021/291/006
Action
2006/08/30
2277 6125
FDA
Z-1410-06
Class II Recall
2006/08/30
Co. Ltd.
2666 1942
SA060152
INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide
Delivery System, Model Number 1605-9000-000
99
SA060153
SA060154
SA060155
SA060156
SA060157
Zimmer Trabecular Metal Reverse Shoulder System
Glenosphere and Base Plate
BioCare Systems LumiWave 1X4 Infrared Therapy Device,
Catalog # LW1X4
A & E Industries Guardian Walker and Guardian 5 inch Walker
Wheel Kits, various models
Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and
Optimin Hollow Fiber Sealed System Membrane
Oxygenators/Reservoirs, various models
MicroVision Medical MicroScan Lens Disposable Plastic Cap
used with MicroScan Video Microscope
SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors
SA060158 Abbott Laboratories Xsystems CA 15-3 controls
FDA
Z-1416-06 to Z-1418-06
Class II Recall
2006/08/30
branch)
2992 0968
FDA
Z-1419-06
Class II Recall
2006/08/30
N/A
N/A
FDA
Z-1420-06 & Z-1421-06
Class II Recall
2006/08/30
N/A
N/A
FDA
Z-1422-06 to Z-1429-06
Class II Recall
2006/08/30
N/A
N/A
FDA
Z-1435-06
Class II Recall
2006/08/30
N/A
N/A
2006/08/31
2919 1362
5 affected units in Hong Kong. Rectification completed.
2006/08/31
2806 4841
Medtronic
International, Ltd.
N/A
MHRA
2006/008/023/291/007
Correction
Action
100
MDCO Ref.
Source of
Local Agent
No.
Information*
(YYYY/MM/DD
)
Boston Scientific
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
SA060003
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
SA060005 Leica M520 Surgical Microscope
Agent Contact
Telephone No.
2960 7117
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
2356 7033
FDA
Z-1162-06
Class II Recall
2006/07/05
Leica Microsystems Ltd. (Hong
Kong)
2564 6699
FDA
Z-1163-06
Class II Recall
2006/07/05
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
Limited
2485 7555
SA060009 Welch Allyn PIC 50 external defibrillator/monitor
FDA
Z-1195-06
Class I Recall
2006/07/07
N/A
N/A
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
SA060013
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
A29
64
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
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
Cardinal Health Extension Set Model G304020M and
SA060027
G400200B
FDA
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
Remarks
Boston Scientific
Hong Kong Ltd.
Boston Scientific
Hong Kong Ltd
Ltd.
N/A
N/A
Recall
Recall
2006/07/07
2960 7117
2006/07/08
Boston Scientific Hong
g Kong
g Ltd.
2960 7117
Kong) Ltd.
Kong) Ltd.
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
2240 6260
Health Canada
30621
Type II Recall
2006/07/10
N/A
N/A
1041
Health Canada
31622
Type II Recall
2006/07/10
2789 3300
MHRA
2006/006/022/291/010
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
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
2006/007/010/291/024
Action
2006/07/12
N/A
N/A
101
149 affected units in Hong
g Kong.
g
1041
Health Canada
MHRA
35 units of the affected models previously supplied in Hong
Kong.
The local agent has informed all affected users. No product
recall was necessary.
SA060028 Hand pendants of Varian C-Series Clinac linear accelerators
FDA
Z-1206-06
Class II Recall
2006/07/12
Disetronic D-TRONplus power packs used in D-TRONplus
SA060029
insulin pumps
FDA
N/A
Firm Press Release
2006/07/13
Action
Recall
Action
Action
Action
Action
MHRA
2006/007/003/291/024
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
Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot
SA060034
52F5
MHRA
2006/007/013/081/004
SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit
MHRA
2006/007/013/291/004
FDA
Z-1196-06
Class II Recall
SA060030 Rocket Sekdubger Chest Drainage Set
SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece 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
sterile),
SA060042 Bard 8F Bard Channel Steerable Shealth
SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator
Medtronic Model 8731 intrathecal catheters and model 8598
SA060044
intrathecal catheter distal revision kits
Cardinal Health (formerly known as ALARIS) IVAC P4000
SA060045
Syringe pump
Inc.
Limited
2724 2836
2485 7597
2006/07/13
N/A
N/A
2006/07/14
2960 7117
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
2006/07/17
2807 8556
2006/07/19
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
FDA
Z-1223-06
Class II Recall
2006/07/19
N/A
N/A
MHRA
2006/007/017/601/173
Medtronic
International, Ltd.
N/A
FDA
N/A
Action
Voluntary Field
Corrective Action
Urgent: Worldwide
Medical Device Recall
2006/07/19
N/A
N/A
2006/07/19
2919 1355
2006/07/21
2919 1362
31 affected units in Hong Kong. Rectification completed.
MHRA
MDA/2006/042
Action
2006/07/24
Health Canada
28894
Type II Recall
2006/07/24
SA060047 Oxoid Imipenem 10ug Discs
Health Canada
31477
Type II Recall
2006/07/24
2802 6333
106 units distributed in Hong Kong.
Health Canada
31861
Type II Recall
2006/07/24
2866 0811
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
2
SA060050 Boston Scientific Cutting Balloon Ultra Monorail Device
Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle SA060051
- Stubby/Short, catalog number 004413300
Novartis Pharmaceuticals (HK)
Ltd.
South East Chemicals &
Instruments Ltd.
N/A
distributed in Hong Kong
Kong.
SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329
SA060048
N/A
2881 4235
31353
Type II Recall
2006/07/24
N/A
N/A
Boston Scientific
Hong Kong Ltd.
N/A
Recall
2006/07/25
2960 7117
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
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
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
2622 9622
N/A
SA060055 Gore Tag Thoracic Endoprosthesis Systems
SA060056
Aksys PHD Personal Hemodialysis System for daily home
hemodialysis, Model 1M101
SA060057 Cordis INFINITI 6 French Diagnostic Catheter
SA060058
Instrumentation Laboratory HemosIL and Hemoliance
RecombiPlasTin, Prothrombin Time Test
FDA
Z-1236-06 & Z-1237-06
Class II Recall
2006/07/26
W.L. Gore & Associates (Hong
Kong) Limited
FDA
Z-1239-06
Class II Recall
2006/07/26
N/A
2738 6080
2792 7773
FDA
Z-1240-06
Class II Recall
2006/07/26
Johnson & Johnson (Medical)
Hong Kong Ltd.
FDA
Z-1246-06 & Z-1247-06
Class II Recall
2006/07/26
Instrumentation Laboratory Ltd.
102
Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02,
Lot Number: J156610 and J156710
Olympus Life and Material Science Europa GmbH SA060060
Immunoglobulin M, OSR6146
Cordis SV-5 and SV-8 Peripheral Steerable Guidewires
SA060061 Catalog 503-558, 503-558X, 503-658, 503-658X (41 specific
lBaxa Ltd.
l ) 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
SA060059
MHRA
2006/006/029/291/002
MHRA
2006/005/015/291/003
MHRA
2006/007/026/081/004
MHRA
2006/007/025/291/014
MHRA
2006/007/021/081/003
MHRA
2006/007/028/291/004
Action
Action
Action
Action
Action
Action
103
2006/07/26
2806 4201
2006/07/26
Olympus Hong Kong Ltd.
2376 1805
2006/07/27
Kong
2738 6080
2006/07/27
N/A
N/A
2006/07/31
Limited
2485 7597
2006/07/31
2240 6260

Major Safety Alerts in September 2008 (This page is subject to

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