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Summary of Field Safety Notices - May 2022
Notice type:
3rd Party Publications
Date:
01/06/2022
Further Information:
Abbott
Absolute Pro LL
Advice regarding the use of the device. HPRA Ref: V51442
Abbott
Alinty hq Analyzer, Alinity hs Slide Maker Stainer Module
Advice regarding a software upgrade. HPRA Ref: V51307
Abbott GmbH & Co. KG
Alinity s HIV Ag/Ab Combo Reagent Kit
Advice regarding a software upgrade. HPRA Ref: V51250
Becton Dickinson Infusion Therapy AB
BD Connecta Stopcock and BD Nexiva with BD Connecta
Advice regarding a device removal. HPRA Ref: V51341
Becton, Dickinson and Company, BD Biosciences
BD™ Anti-Kappa & BD OneFlow™ FSN 1
BD™ Anti-Kappa & BD OneFlow™ FSN 2
Advice regarding a device removal. HPRA Ref: V51225
Bio-Rad Medical Diagnostics GmbH
Anti-Lua (LU1)
Advice regarding a device modification. HPRA Ref: V51420
bioretec
Activa IM-Nail™
Advice regarding the use of the device. HPRA Ref: V51363
COBES
Surgical Kit, Isolation Gowns, Surgical Gowns, Medical Cap, Surgical drapes, Suits
Advice regarding the use of the device. HPRA Ref: V51154
Cook Incorporated
Hilal. Nester®, Tornado® Embolization Microcoil
Advice regarding a device removal. HPRA Ref: V51238
Datex-Ohmeda, Inc.
Carescape R860, Engström Carestation, Engström Pro
Advice regarding the use of the device. HPRA Ref: V51423
DNA Genotek Inc
ORAcollect DNA / ORAcollect RNA / ORAcollect Dx FSN 1
ORAcollect DNA / ORAcollect RNA / ORAcollect Dx FSN 2
Advice regarding the use of the device. HPRA Ref: V50705
Drägerwerk AG & Co. KGaA
SafeStar 55
Advice regarding a device removal. HPRA Ref: V51251
GE healthcare
Centricity Universal Viewer Zero Footprint Client (ZFP), Centricity PACS RA1000 Workstation (RA1000), Centricity Radiology RA600 (RA600), Centricity Cardiology CA1000 (CA1000) and Centricity Enterprise Web (CWeb)
Advice regarding a software upgrade. HPRA Ref: V51447
Getinge
VOLISTA Standop surgical light
Advice regarding a device modification. HPRA Ref: V51327
Instrumentation Laboratory Co
Heparin Anti-xa
Advice regarding changes/updates made to instructions for use. HPRa Ref: V51038
Leica BioSystems
ASP6025, Leica ASP300 S, Leica ASP200 S, HistoCore PEARL, HistoCore Spectra ST
Advice regarding a device modification. HPRA Ref: V51490
Maquet Cardiopulmonary GmbH
Heater Unit HU 35
Advice regarding a device modification. HPRA Ref: V51324
Medtronic
EEA™ Autosuture™ Circular Stapler with DST Series™ Technology, 25mm
Model Numbers – EEA25, EEAXL25, EEA2535, EEAXL2535
Advice regarding a device removal. HPRA Ref: V51005
Medtronic
MiniMed™ 600 and 700 series insulin pumps FSN 1
MiniMed™ 600 and 700 series insulin pumps FSN 2
Advice regarding a device modification. HPRA Ref: V51484
Medtronic Xomed, Inc.
Medtronic NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACTTM Reinforced EMG Endotracheal Tube
Advice regarding changes/updates made to instructions for use. HPRA Ref: V51301
Menarini Silicon Biosystems
CELLSEARCH® Circulating Tumor Cell Kits (IVD),
Advice regarding a device removal. HPRA REf: V51494
Olympus
DISPOSABLE GRASPING FORCEPS
Advice regarding a device removal. HPRA Ref: V51002
Olympus
Soltive SuperPulsed Laser Fiber 150 Micron
Advice regarding a device removal. HPRA Ref: V51311
Ortho Clinical Diagnostics
ORTHO VISION and VISION Max Analyzers
Advice regarding a software upgrade. HPRA Ref: V51155
Ossur
Vari-Flex Junior
Advice regarding the use of the device. HPRA Ref: V51459
Philips Goldway (Shenzhen) Industrial Inc.
Philips HeartStart Intrepid Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: V46760
Phoenix s.r.l.
Volumed® Set
Advice regarding a device removal. HPRA Ref: V51315
Radiometer Medical Aps
ABL700 and ABL800 Flex Analyzer
Advice regarding a software upgrade. HPRA Ref: V51280
Roche Diabetes Care GmbH
Accu-Chek® Insight Adapter & Tubing
Advice regarding a device removal. HPRA Ref: V51412
Siemens Healthcare Diagnostics Inc.
ADVIA® 2120 Hematology Systems and ADVIA® 2120i Hematology Systems
Advice regarding a software upgrade. HPRA Ref: V45940
Siemens Healthcare GmbH
ARTIS icono biplane
Advice regarding a device modification. HPRA Ref: V51446
ulti med Products (Deutschland) GmbH
Ulti med/Omega hCG Pregnancy Test Cassette
Advice regarding a device removal. HPRA Ref: V51256
VitreQ B V
CryoTreQ
Advice regarding a device removal. HPRA Ref: V51429
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Date Printed: 02/12/2022