Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
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
« Back
Date Printed: 19/04/2024