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Field Safety Notices- July 2014
Notice type:
3rd Party Publications
Date:
07/08/2014
Further Information:
Abbott Laboratories
Clinical Chemistry ICT Serum Calibrator
Advice regarding the use of the device - HPRA Ref: V21461
Abbott Molecular Inc
.
5mL Reaction Vessels
Advice regarding the use of the device - HPRA Ref: V21328
ArcRoyal Limited
CPT's Custom procedural Trays
Advice regarding the use of the device - HPRA Ref: V21163
B.Braun Medical SAS
Celiste PICC-Cel
Advice regarding the use of the device - HPRA Ref: V21405
Baxter Healthcare SA
COSEAL Surgical Sealant 4ml
Advice regarding a device removal - HPRA Ref: V21486
Beckman Coulter
UniCel DxH 800 and 600 Cellular Analysis Systems
Advice regarding the use of the device - HPRA Ref: V19242
Beckman Coulter
LH 750 and LH 780 Hematology Systems
Advice regarding the use of the device - HPRA Ref: V19240
Becton Diagnostics
BD Vacutainer® CPTTM (Cell Preparation Tube)
Advice regarding a device removal - HPRA Ref: V21270
Creganna Tactx Medical
Cordis EMPIRA NC RX PTCA Dilatation Catheter ("75RxxyyyN") and Cordis EMPIRA RX PTCA Dilatation Catheter ("85RxxyyyS")
Advice regarding the use of the device - HPRA Ref: V21148
DePuy Orthopaedics Inc.
RECLAIM® Taper Sleeve Protector Instrument
Advice regarding a device removal - HPRA Ref: V21205
DePuy Synthes
-ROM Noiles Rotating Hinge Femur with Pin
Advice regarding a device removal - HPRA Ref: V20219
EcoLab / Microtek Medical B.V.
Basin Liner
Advice regarding a device removal - HPRA Ref: V21061
Gambro
Ultrafilter U9000
Advice regarding the use of the device - HPRA Ref: V21524
GE Healthcare
Proteus XR/a and Revolution XR/d
Advice regarding a device modification - HPRA Ref: V21215
GE Healthcare
CARESCAPETM Monitor B850, B650 or B450
Advice regarding a software upgrade HPRA Ref: V21103
GE Healthcare
Neuromuscular Transmission Module Version 01 (E-NMT-01) showing wrong values with the ElectroSensor
Advice regarding a software upgrade - HPRA Ref: V21330
Integra LifeSciences Corporation (Integra)
Camino® Intracranial Pressure Monitoring Kits
Advice regarding changes/updates made to instructions for use - HPRA Ref: V21358
Invacare
Aquatec® Ocean VIP - Tilting
Advice regarding a device modification - HPRA Ref: V20791
Invivo, a division of Philips Medical Systems
Philips Expression IP5 Information Portal
Advice regarding a device modification - HPRA Ref: V21425
Koo Medical Equipment (Shanghai) Co., Ltd.
Catheter Mount. Cath Mt Conn 22mm OD/15mm ID (50) and Exp Cath Mt w/h Bact/HME filt (50)
Advice regarding a device removal - HPRA Ref: V21462
Maquet Cardiopulmonary AG
PLEGIOX Cardioplegia Heat Exchanger
Advice regarding a device removal - HPRA Ref: V20232
Medo International SARL
CODMAN CERTAS Programmable Valves
Advice regarding the use of the device - HPRA Ref: V21413
MERU
TravelChair
Advice regarding the use of the device - HPRA Ref: V21203
Mindray DS USA Inc.
V-Series Monitoring System
Advice regarding the use of the device - HPRA Ref: V21155
Mölnlycke Health Care AB
Mölnlycke Health Care ProcedurePak®
Advice regarding a device removal- HPRA Ref: V21307
Nihon Kohden Europe GmbH
Cardiofax M ECG-2350
Advice regarding a software upgrade - HPRA Ref: V21387
Olympus Medical
Evis Exera II Video Duodenoscope TJF-Q180V
Advice regarding changes/updates made to instructions for use - HPRA Ref: V21483
Ortho Clinical Diagnostics
"VITROS® 3600 Immunodiagnostic Systems, VITROS® 4600 Chemistry Systems &
VITROS® 5600 Integrated Systems"
Advice regarding a software upgrade - HPRA Ref: V21334
PerkinElmer
Specimen Gate Screening Center
Advice regarding the use of the device - HPRA Ref: V21241
Peters Surgical
CARDIOXYL, CARDIOFLON, Evolution and SURGIKIT
Advice regarding a device removal - HPRA Ref: V21143
Philips Healthcare
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center IX (PIIC iX), 865350, 865351, 865352
Advice regarding a software upgrade - HPRA Ref: V21065
Philips Healthcare
Ingenia MRI
Advice regarding a device modification - HPRA Ref: V21225
Philips Healthcare UK
MobileDiagnost wDR
Advice regarding a device modification - HPRA Ref: V21271
Philips Medical Systems
BrightView XCT Imaging System
Advice regarding a device modification - HPRA Ref: V21357
Physio-Control UK
LIFEPAK 1000 Defibrillator
Advice regarding the use of the device - HPRA Ref: V21326
PMH- Produtos Médico Hospitalares, SA
IV EXTENSION LINE POE/PVC 1.00x3.00mm, WITH A FIXE
Advice regarding a device removal - HPRA Ref: V21459
Radiometer Medical Aps
RADIANCE system
Advice regarding a software upgrade - HPRA Ref: V21539
Roche Diagnostics
cobas b 221 system
Advice regarding the use of the device - HPRA Ref: V21332
Siemens AG / Healthcare Sector / Geschäftsgebiet AX
Artis zee, Artis zeego, Artis Q Artis Q zen
Advice regarding a software upgrade - HPRA Ref: V21391
Siemens Healthcare Diagnostics
VERSANT HCV 2.0 Genotype Assay (LiPA)
Advice regarding a device removal - HPRA Ref: V21274
Smiths Medical International Inc.
Portex® Endotracheal Tube Holders, 2.5mm and 3.0mm
Advice regarding a device removal - HPRA Ref: V21354
Sorin Group
Cardiac Surgery Mycobacterium Risks Disinfection and Cleaning of Sorin Heater Cooler Devices
Advice regarding the use of the device - HPRA Ref: V21430
Stryker Instruments
Sonopet Ultrasonic Aspirator Console
Advice regarding a device modification - HPRA Ref: V21407
Synthes
Synthes Trauma External Fixation System
Advice regarding the use of the device - HPRA Ref: V20584
Terumo BCT
Spectra Optia® Apheresis System
Advice regarding a software upgrade - HPRA Ref: V14706
Thermofisher Scientific
Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum
Advice regarding the review of patient results/patient recall/sample retesting is required - HPRA Ref: V21543
Varian Medical Systems Inc.
C-Series High Energy Linear Accelerator
Advice regarding the use of the device - HPRA Ref: V21159
Vascutek Ltd
Gelsoft™, Gelsoft Plus™, K-Thin, Gelseal™, Gelseal Plus™ and Gelweave™ Vascular Prostheses; Thoraflex™ Hybrid Devices; BioValsalva™ Stentless Biplex™ Conduits;Stented BioValsalva™ Biplex™ Conduits; RVOT elan™ Biplex™ Conduits
Advice regarding the use of the device - HPRA Ref: V21344
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Date Printed: 16/04/2024