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 2020
Notice type:
3rd Party Publications
Date:
02/10/2020
Further Information:
Summary of Field Safety Notices - September 2020
Abbott
Alinity s Anti-HBc Reagent Kit
Advice regarding a software upgrade. HPRA Ref: V44743
American Medical Systems (Boston Scientfic Ltd.)
AMS 700™ with MS Pump™
Advice regarding a device removal. HPRA Ref: V44778
Apollo Endosurgery, Inc.
LAP-BAND System and Accessories - FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44632
LAP-BAND System and Accessories - Patient Card
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44632
Armstrong Medical Ltd
15mmØ Collapsible/Extendible Tubing
Advice regarding the use of the device. HPRA Ref: V44871
BD / CME
T34 Ambulatory Syringe Pump
Advice regarding the use of the device. HPRA Ref: V44795
Beckman Coulter, Inc.
Access Unconjugated Estriol
Advice regarding the use of the device. HPRA Ref: V44808
Bien-Air Surgery SA
OSSEODUO/OSSEOUNO/OSSEODOC/OSSEOSTAP control units
Advice regarding a device modification. HPRA Ref: V44801
Blink Medical
Liposuction Cannula
Advice regarding a device removal. HPRA Ref: V44853
Boston Scientific
Hurricane™ RX Biliary Balloon Dilatation Catheter
Advice regarding a device removal. HPRA Ref: V44761
Dako North America, Inc.
Autostainer Link 48/Plus/Classic
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44712
Dräger Medical GmbH
Perseus A500
Advice regarding a device modification. HPRA Ref: V44802
Fannin Ltd
CHROMagar E.coli O157 + Cefixime/Tellurite
Advice regarding a device removal. HPRA Ref: V44664
Fresenius Medical Care AG & Co. KGaA
AquaC UNO H
Advice regarding the use of the device. HPRA Ref: V44710
FUJIFILM Corporation
FUJIFILM 580-U Series and 700 Series Flexible Colono & Gastroscope
Advice regarding the use of the device. HPRA Ref: V44870
GBUK Group
Caretip 5ml Oral Dispenser Sterile
Advice regarding the use of the device. HPRA Ref: V44751
Getinge/Maquet
Intra-Aortic Balloon Catheters
Advice regarding a device removal. HPRA Ref: V44528
MEERA, YUNO, YUNO II - O.R Beds
Advice regarding a device modification. HPRA Ref: V44788
ICU Medical Inc
Spiros
Advice regarding a device removal. HPRA Ref: V44753
IMACTIS
IMACTIS CT-Navigation™ Workstation
Advice regarding a device modification. HPRA Ref: V44736
Intuitive Surgical Inc.
Endoscope/Camera Sterilization Trays
Advice regarding the use of the device. HPRA Ref: V42478
Inzek International Trading
BIOZEK COVID-19 IgG/IgM Rapid Test Cassette (single test)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44822
Jenx
Dreama Slim Support Pad
Advice regarding a device removal. HPRA Ref: V44890
Life Technologies Corporation, a part of Thermo Fisher Scientific
TaqPath™ COVID-19 CE-IVD Interpretive Software
Advice regarding a software upgrade. HPRA Ref: V44413
Maquet Cardiopulmonary GmbH
Blood Monitoring Unit BMU 40
Advice regarding a device modification. HPRA Ref: V44834
Medtronic Inc.
Rashkind Balloon Septostomy Catheters
Advice regarding a device removal. HPRA Ref: V44786
Mentor
Mentor Breast Tissue Expander
Advice regarding the use of the device. HPRA Ref: V44699
Micro Therapeutics, Inc.
Pipeline Flex Embolization device - Bare metal Intracranial vascular stent
Advice regarding the use of the device. HPRA Ref: V44764
Philips Goldway (Shenzhen) Industrial Inc.
Philips Efficia DFM100 Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: V44750
Philips Healthcare (Invivo Corporation)
Various MRI system coils
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44867
Philips Medical Systems
Philips Sterilizable Switched Internal Defibrillator Paddles
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44862
Respironics California, LLC
Philips V60 Ventilator
Advice regarding a device modification. HPRA Ref: V43219
Siemens Healthcare Diagnostics Inc
Chemistry Calibrator
Advice regarding the use of the device. HPRA Ref: V44001
Siemens Healthcare GmbH
Artis icono and Artis pheno
Advice regarding a software upgrade. HPRA Ref: V44847
Smith & Nephew
Suture Based Repair Systems
Advice regarding a device removal. HPRA Ref: V44814
Stryker GmbH
Osteosynthesis Compression Staple EasyClip
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44877
W.L. Gore & Associated B.V.
GORE TAG Conformable Thoracic Stent Graft
Advice regarding the use of the device. HPRA Ref: V44792
GORE TAG Conformable Thoracic Stent Graft
Advice regarding the use of the device. HPRA Ref: V44793
« Back
Date Printed: 09/11/2024