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Summary of Field Safety Notice – November 2015
Notice type:
3rd Party Publications
Date:
02/12/2015
Further Information:
B.Braun
Dialog+ SW 9.xx Dialysis Machines
Advice regarding the use of the device. HPRA Ref V26116
Bayer Healthcare
CONTOUR®NEXT control solutions
Advice regarding changes/updates made to instructions for use. HPRA Ref V26121
BioMerieux
ATB™ Densitometer control kit
Advice regarding a device removal. HPRA Ref V26007
BioMerieux
MYLA® - All Software versions
Advice regarding a software upgrade. HPRA Ref V26068
BioMerieux
ETEST® PIP/TAZO/CON-4 PTC 256
Advice regarding a device removal. HPRA Ref V26179
Biosense Webster
CARTOSOUND Module in conjunction with SOUNDSTAR eco 8F and eco 10F Catheters
Advice regarding the use of the device. HPRA Ref V25768
Boston Scientific
Chariot™ Guiding Sheath
Advice regarding a device removal. HPRA Ref V26127
BrainLab AG
Brain Metastases, Adaptive Hybrid Surgery Analysis
Advice regarding a software upgrade. HPRA Ref V26122
Cardica, Inc.
MicroCutter XCHANGE® 30 Blue Cartridge and MicroCutter XCHANGE® 30 Blue Curved Tip Cartridge
Advice regarding a device removal. HPRA Ref V26130
Cook Medical
EchoTip Ultra Endobronchial High Definition Ultra
Advice regarding changes/updates made to instructions for use. HPRA Ref V26168
Fannin
W11050 Columbia Blood Agar
Advice regarding a device removal. HPRA Ref V25997
Hospira Inc.
Plum A+ Family of Infusers
Advice regarding changes/updates made to instructions for use. HPRA Ref V24783
IBA Dosimetry GmbH
Lifting Table (Water Phantom Carriage)
Advice regarding a device modification. HPRA Ref V26174
Invivo Corporation (Philips Healthcare)
Flex Cardio Patient Monitoring System
Advice regarding a software upgrade. HPRA Ref V26032
Leonhard Lang GmbH
ECG Electrode
Advice regarding a device removal. HPRA Ref V26031
Lloyds Pharmacy
Lloyds Pharmacy Own Brand Digital Forehead and Ear Thermometer
Advice regarding the use of the device. HPRA Ref V25806
Maquet
Quadrox-iD Adult/Small Adult - HLS Set Advanced / HIT Set Advanced / PLS Set / HIT Set PLS / HIT Set PLS Plus
Advice regarding a device removal. HPRa Ref V26115
Medtronic Inc
InSync III Cardiac Resynchronization Therapy Pacing (CRT-P)
Advice regarding the use of the device. HPRA Ref V26035
Origio
Flushing Medium w/wo Heparin
Advice regarding changes/updates made to instructions for use. HPRA Ref V26188
Philips
Allura Xper FD R8.2.0
Advice regarding a software upgrade. HPRA Ref V26026
Philips Medical Systems B.V.
All Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems
Advice regarding a software upgrade. HPRA Ref V26096
Piaoan International China Co., Ltd.
Absorbent Pad (Part 100605)
Advice regarding a device removal. HPRA Ref V25973
Qiagen
Artus C. trachomatis Plus kits
Advice regarding changes/updates made to instructions for use. HPRA Ref V26065
Quidel Corporation
Sofia Legionella FIA
Advice regarding changes/updates made to instructions for use. HPRA Ref V26015
Siemens Healthcare Diagnostics Inc.
Acute Care TeskPaks; Acute Care CTNI, Acute Care pBNP, Acute Care DDMR, Acute Care MYO, Acute Care CKMB, Acute Care CCRP, Acute Care BHCG, Acute Care CCRP, Acute Care BHCG, Acute Care MYO, Acute Care CKMB
Advice regarding a device modification. HPRA Ref V26061
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur and ADVIA Centaur XP
Advice regarding a device modification. HPRA Ref V26103
Smith & Nephew Orthopaedics Ltd.
BIRMINGHAM HIP™ Modular Head, monoblock version
Advice regarding the use of the device. HPRA Ref V26104
Terumo Medical Corporation
Terumo® Destination® Renal Guiding Sheath
Advice regarding a device removal. HPRA Ref V26123
Thermofisher
OXOID ANTIMICROBIAL SUSCEPTIBILITY TESTING DISC PENICILLIN G (P1), CT0152B LOT 1675623: D.O.M 08.05.2015
Advice regarding a device removal. HPRA Ref V26146
Various 3rd party manufacturers, used with Philips computed tomography
Uninterruptible Power Supply (UPS) - Accessory Device
Advice regarding the use of the device. HPRA Ref V23781
Vascular Solutions, Inc.
TurnPike™ Spiral and TurnPike Gold catheters, Models 5621, 5630, 5640, 5641
Advice regarding changes/updates made to instructions for use. HPRA Ref V25010
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Date Printed: 26/04/2024