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Summary of Field Safety Notices - July 2017
Notice type:
3rd Party Publications
Date:
01/08/2017
Further Information:
Baxter
Prismaflex Control Unit
Advice regarding a software upgrade. HPRA Ref: V31035
Baxter Healthcare Corporation
HomeChoice or HomeChoice PRO Cyclers. FSN 1-Home Patient
HomeChoice or HomeChoice PRO Cyclers. FSN 2 - Hospital
Advice regarding the use of the device. HPRA Ref: V32699
BD Life Sciences
BD MAX™ Vaginal Panel / BD MAX™ UVE Specimen Collection Kit
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32614
BioMérieux Inc
VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards
Advice regarding the use of the device. HPRA Ref: V31635
Boston Scientific
Encore™ 26 Inflation Device Single Pack
Advice regarding the use of the device. HPRA Ref: V32063
Dysis Medical
DYSIS Digital Colposcope_DYS302
Advice regarding the use of the device. HPRA Ref: V32343
Elekta
iGUIDE Software 2.2
Advice regarding a software upgrade. HPRA Ref: V32356
Getemed
HL7 Worklist Server/Commander
Advice regarding a software upgrade. HPRA Ref: V32396
Helena Biosciences
APTT Si L Minus
Advice regarding a device removal. HPRA Ref: V32373
Hologic Inc
Tomcat Instruments
Advice regarding a software upgrade. HPRA Ref: V32339
Horiba ABX SAS
Yumizen H500CT
Advice regarding a device modification. HPRA Ref: V32516
Joerns Healthcare
Oxford Dipper
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32409
LivaNova
PLANTINIUM ICDs and CRT-Ds
Advice regarding a device removal. HPRA Ref: V32645
Maquet/Getinge
Maquet/Datascope CS100i, CS100, CS300 Intra-Aortic Balloon Pumps (IABP)
Advice regarding a device modification. HPRA Ref: V32583
Medtronic
Euphora Rapid Exchange Balloon Dilatation Catheter / Solarice Rapid Exchange Balloon Dilatation Catheter
Advice regarding a device removal. HPRA Ref: V32480
Melius Pro B.V.
Simple Up CL
Advice regarding a device modification. HPRA Ref: V32190
Novo Nordisk
NovoPen Echo® and NovoPen® 5
Advice regarding a device removal. HPRA Ref: V32407
Olympus Medical Systems Corporation
Flexible Video Duodenoscope
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32596
One Lambda - Thermo Fisher Scienfiic
AllSet+™ Gold SSP
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32464
Ortho Clinical Diagnostics
ORTHO BioVue® System (Rh/K Cassette)
Advice regarding a device removal. HPRA Ref: V32563
Ossur Hf
Rebound Foot Up
Advice regarding a device removal. HPRA Ref: V32571
Ottobock
Voyager Evo rigid frame wheelchair
Advice regarding the use of the device. HPRA Ref: V32549
PHYSIO-CONTROL, INC
LIFEPAK® 15 MONITOR/DEFIBRILLATOR with End-Tidal CO2 option
Advice regarding a device modification. HPRA Ref: V32595
Radiometer Medical Aps.
ABL90 Flex and ABL90 Flex Plus
Advice regarding a software upgrade. HPRA Ref: V29183
Richard Wolf GmbH
PUNCH W 4.6MM H 1.6MM
Advice regarding a device removal. HPRA Ref: V32673
Roche
Accu-Chek® Insight. FSN 1
Accu-Chek® Insight. FSN 2
Accu-Chek® Insight. Attachment
Advice regarding the use of the device. HPRA Ref: V24535
Roche
CFSN cobas 8000 core unit SBN-CPS-2017-017
Advice regarding a software upgrade. HPRA Ref: V32622
Roche Diabetes Care
Accu-Chek Insight E-7
Advice regarding the use of the device. HPRA Ref: V32657
Roche Diagnostics
cobas e 411 analyzer (disk system), cobas e 411 analyzer (rack system)
Advice regarding a software upgrade. HPRA Ref: V32300
Roche Diagnostics
Elecsys 2010 analyzer (disk system), Elecsys 2010 analyzer (rack system)
Advice regarding the use of the device. HPRA Ref: V32300
Roche Diagnostics
Elecsys Digoxin
Advice regarding the use of the device. HPRA Ref: V32452
Roche Diagnostics
cobas c 501 module / cobas c 502 module
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32525
Sebia
Capillarys Immunotyping, Minicap Immunotyping, CAPI 3 Immunotyping
Advice regarding the use of the device. HPRA Ref: V32613
SeraCare Life Sciences
ACCURUN® 51 Multi-Marker Hepatitis Positive Control
Advice regarding the use of the device. HPRA Ref: V32411
Siemens Healthcare GmbH
Lantis System / Lantis Commander. FSN1
Lantis System / Lantis Commander. FSN2
Advice regarding a software upgrade. HPRA Ref: V32419
Siemens Healthcare GmbH
Lantis System (Pre 2003), RTT 4.1 / RTT 4.1 Assist, RTT 1.6
Advice regarding the use of the device. HPRA Ref: V32419
Siemens Healthcare GmbH
Spect, Spect.CT, PET, PET.CT Systems and Workplaces
Advice regarding a software upgrade. HPRA Ref: V32531
Siemens Healthcare GmbH
Dimension Assays / Dimension Vista Assays / Syva Assays. FSN 1
Dimension Assays / Dimension Vista Assays / Syva Assays. FSN 2
Advice regarding the use of the device. HPRA Ref: V32552
Siemens Healthcare GmbH
Artis systems, X-Workplace, Sensis and Arcadis systems
Advice regarding a software upgrade. HPRA Ref: V32658
Siemens Healthcare GmbH
Syngo Workflow MLR
Advice regarding a software upgrade. HPRA Ref: V32384
Stanmore Implants Worldwide
JTS Grower Drive Unit, MLE 3
Advice regarding a device removal. HPRA Ref: V32423
Teleflex Medical
Percuvance® Percutaneous SurgicalSystem
Advice regarding a device removal. HPRA Ref: V32587
ThermoFisher Scientific
ThermoScientific™ Oxoid™ GC Agar, CM0367 (B,R,T,Q,K)
Advice regarding a device removal. HPRA Ref: V32447
Wilson Instruments (Shanghai) Co. Ltd.
Disposable Cleaning Brush
Advice regarding the use of the device. HPRA Ref: V32698
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Date Printed: 27/04/2024