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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
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Date Printed: 28/01/2021