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 - September 2021
Notice type:
3rd Party Publications
Date:
04/10/2021
Further Information:
Summary of Field Safety Notices - September 2021
Abbott Molecular Inc
Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kit
Advice regarding the use of the device. HPRA Ref: V47379
Abbott USA
EnSite X Display Workstation
Advice regarding a software upgrade. HPRA Ref: V47523
Acumed LLC
Medium Ratcheting Driver Handles
Advice regarding a device removal. HPRA Ref: V47483
Advanced Surgical Concepts
PneumoLiner
Advice regarding a device removal. HPRA Ref: V47475
Aesculap AG
Bipolar Cup Trial Head
Advice regarding the use of the device. HPRA Ref: V47469
Agilent Technologies, Inc.
EnVision FLEX Hematoxylin (Link) Kit
Advice regarding a device removal. HPRA Ref: V47376
Baxter
Central Water Plant (CWP) 800 Systems
Advice regarding a device modification. HPRA Ref: V46354
Biodex Medical Systems Inc.
AtomLab™ 500 Dose Calibrator and AtomLab™ 500Plus Dose Calibrator
Advice regarding a software upgrade. HPRA Ref: V47485
bioMérieux SA
VIDAS® Immuno-Assays Multiple references
Advice regarding the use of the device. HPRA Ref: V47530
MYLA V4.7 software and MYLA V4.8 software
Advice regarding a software upgrade. HPRA Ref: V47455
Cook Medical
Single Lumen and Double Lumen Ovum Pick-Up Needles
Advice regarding the use of the device. HPRA Ref: V47302
Datascope Corp. Getinge
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device. HPRA Ref: V47429
Cardiosave Li-Ion Battery Pack
Advice regarding a device removal. HPRA Ref: V47505
Datex-Ohmeda, Inc.
Flow Sensors used in GE Healthcare / Datex-Ohmeda Anaesthesia Machines
Advice regarding the use of the device. HPRA Ref: V47358
Eden Innovations
DOC fixed and DOC mobile accessory of Philips HS1 defibrillator
Advice regarding a device removal. HPRA Ref: V42868
Elekta
Linear Accelerator
Advice regarding the use of the device. HPRA Ref: V47438
Getinge
Atrium Pneumostat Chest Drain Valve
Advice regarding the use of the device. HPRA Ref: V47354
Labratoire CCD
1ml IVF and AI Syringes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42165
Medtronic
LINQ II Insertable Cardiac Monitor
Advice regarding the use of the device. HPRA Ref: V46738
Activa Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V47453
Medtronic Xomed Inc
Sterile Blade Single-Use Accessories - Updated FSN
Advice regarding a device removal. HPRA Ref: V47351
Microbiologics Inc.
HE™Synthetic Standard SARS-CoV-2 Process Control (Swab)
Advice regarding the use of the device. HPRA Ref: V47420
HE™Synthetic Standard SARS-CoV-2 Process Control (Pellet)
Advice regarding the use of the device. HPRA Ref: V47427
MILESTONE S.R.l.
SEALSAFE, llSSUESAFE PLUS
Advice regarding a device removal. HPRA Ref: V47363
OPHTEC BV
Artisan and Artiflex phakic intraocular lenses (PIOLs)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47470
Paradigm Spine GmbH
HPS 2.0™ Rod coupler ; HBI95527 / HBI95527
Advice regarding a device removal. HPRA Ref: V46476
Philips Ultrasound, Inc.
Philips EPIQ & Affiniti Ultrasound Systems
Advice regarding the use of the device. HPRA Ref: V47415
Roche Diagnostics GmbH
cobas c 503 TDM Vancomycin, Gentamicin, Phenytoin, Theophylline, Phenobarbital
Advice regarding a software upgrade. HPRA Ref: V46429
cobas® EGFR Mutation Test v2
Advice regarding the use of the device. HPRA Ref: V47334
Siemens Healthcare Diagnostics Limited
Atellica CH and ADVIA Urinary/Cerebrospinal Fluid - FSN 1
Advice regarding a software upgrade. HPRA Ref: V47435
Atellica CH and ADVIA Urinary/Cerebrospinal Fluid - FSN 2
Advice regarding a software upgrade. HPRA Ref: V47435
Smiths Medical
LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems
Advice regarding the use of the device. HPRA Ref: V47220
Sunrise Medical
Zippie Voyage®
Advice regarding a device modification. HPRA Ref: V47228
The Spectranetics Corporation
Bridge® Occlusion Balloon
Advice regarding the use of the device. HPRA Ref: V47356
W.L Gore & Associates
GORE Cardioform Septal Occluder
Advice regarding a device removal. HPRA Ref: V47346
Welch Allyn Inc.
ELI®280, MLBUR280 and BUR280 Electrocardiographs - FSN 2
Advice regarding a software upgrade. HPRA Ref: V47214
William Cook Europe ApS
Inferior Vena Cava (IVC) Filter
Advice regarding the use of the device. HPRA Ref: V47440
Zimmer Biomet
ROSA One 3.1 Brain application
Advice regarding a software upgrade. HPRA Ref: V47499
« Back
Date Printed: 18/04/2024