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Summary of Field Safety Notices - June 2020
Notice type:
3rd Party Publications
Date:
02/07/2020
Further Information:
Summary of Field Safety Notices - June 2020
Abbott
Alinity ci-series System Control Module - FSN A
Advice regarding a software upgrade. HPRA Ref: V44192
Alinity ci-series System Control Module - FSN B
Advice regarding a software upgrade. HPRA Ref: V44192
Bard Access Systems, Inc
BARD SafeStep™ Huber Needle Sets
Advice regarding a device removal. HPRA Ref: V44216
Biosense Webster Ltd.
CARTO® 3 System Version V7.1.80, CARTO VISITAG® Module
Advice regarding a software upgrade. HPRA Ref: V44206
Dexcom
Dexcom G4 PLATINUM and Dexcom G5 Mobile Receiver
Advice regarding the use of the device. HPRA Ref: V43958
Ethicon LLC
8-0 Blue Twisted Silk Suture
Advice regarding a device removal. HPRA Ref: V44501
Fannin LIP Galway
MUELLER HINTON AGAR + 5% BLOOD & NAD (4mm)(EUCAST)
Advice regarding a device removal. HPRA Ref: V43734
Galil Medical Ltd
IceFORCE & IcePearl 2.1 CX Cryoablation Needles
Advice regarding a device removal. HPRA Ref: V44018
GE Healthcare
CARESCAPE Patient Data Module (PDM)
Advice regarding a software upgrade. HPRA Ref: V43990
Medtronic Inc.
CareLink Programmer; CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V37585
CareLink SmartSync™ Device Managers
Advice regarding a software upgrade. HPRA Ref: V44020
Medtronic Xomed, Inc.
Console IPC-ENT, Microdebrider M5 multi-purpose surigcal power tool system
Advice regarding a device removal. HPRA Ref: V44130
Prodimed
Sterile Single Use Prodimed Medical Devices
Advice regarding a device removal. HPRA Ref: V43953
ResMed
Stellar 100/ Stellar 150
Advice regarding a software upgrade. HPRA Ref: V44074
Roche Diagnostics GmbH
Elecsys Anti-CCP - FSN Updated
Advice regarding the use of the device. HPRA Ref: V40624
Roche Molecular Systems
MagNA Pure 96 System
Advice regarding a software upgrade. HPRA Ref: V44025
Siemens Healthcare Diagnostics Inc
Chemistry Calibrator - FSN 1
Advice regarding the use of the device. HPRA Ref: V44001
Chemistry Calibrator - FSN Updated
Advice regarding the use of the device. HPRA Ref: V44001
Smith & Nephew Inc., USA
SUTUREFIX ULTRA 1.7mm Drill (S)
Advice regarding a device removal. HPRA Ref: V44227
Stryker Medical
LIFEPAK® 500 AED - FSN
Advice regarding the use of the device. HPRA Ref: V44148
LIFEPAK® 500 AED - DiscontinuationLetter
Advice regarding the use of the device. HPRA Ref: V44148
Teleflex Medical
Arrow® FlexTip Plus(R) Epidural Kit with NRFit(R) connector
Advice regarding a device removal. HPRA Ref: V43959
Various Manufacturers
Paclitaxel-coated Balloons and Paclitaxel-Eluting Stents
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38414
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Date Printed: 24/04/2024