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Summary of Field Safety Notices - April 2022
Notice type:
3rd Party Publications
Date:
05/05/2022
Further Information:
3M Deutschland GmbH
3M Nexcare™ ColdHot Therapy pack
Advice regarding the use of the device. HPRA Ref: V51049
Abbott
Merlin and Merlin 2 Patient Care System (PCS)
Advice regarding a software upgrade. HPRA Ref: V50728
Abbott Medical
Dragonfly Opstar Imaging Catheter
Advice regarding a device removal. HPRA Ref: V50964
ArjoHuntleigh AB
Arjo Sara Plus lift
Advice regarding a device modification. HPRA Ref: V50807
Arrow International LLC (Subsidiary of Teleflex Incorporated)
Arrow® Kits and Sets with Introducer Needles
Advice regarding the use of the device. HPRA Ref: V46613
Avanos Medical, Inc.
CORTRAK* 2 Enteral Access System (EAS)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V50968
B. Braun Surgical
MonoPlus
Advice regarding a device removal. HPRA Ref: V51105
Baxter Healthcare SA
EASYGRIP FLO-41 Precision MIS Delivery system
Advice regarding a device removal. HPRA Ref: V50974
Breas Medical AB
Vivo 45, Vivo 45LS, Nippy 4, Nippy 4+
Advice regarding a software upgrade. HPRA Ref: V50920
Drägerwerk AG
Zeus/ Zeus kit C500/ Zeus IE with DIVA Sevoflurane
Advice regarding a software upgrade. HPRA Ref: V50884
GE Healthcare/GE Medical Systems
Various MR Systems
Advice regarding the use of the device. HPRA Ref: V50869
GE Medical Systems Information Technologies, Inc.
Carescape Central Station
Advice regarding a software upgrade. HPRA Ref: V51036
GM Instruments
ASRA Curve Screening Audiometer
Advice regarding a software upgrade. HPRA Ref: V50932
Instrumentation Laboratory Co.
ACL TOP 300 CTS, ACL TOP 350 CTS, ACL TOP 500 CTS, and ACL TOP 550 CTS
Advice regarding the use of the device. HPRA Ref: V50744
Intersurgical Ltd
10MM FLEXTUBE NEONATAL RESUSCITATION BREATHING SYSTEMS
Advice regarding a device removal. HPRA Ref: V50957
Life Technologies Corporation, a part of Thermo Fisher Scientific
TaqPath™ COVID‑19 HT Kit
Advice regarding a device modification. HPRA Ref: V51140
Macopharma UK
LCRD2 filter LQT614B and NQT614B
Advice regarding the use of the device. HPRA Ref: V51229
Medtronic Inc.
Vanta with AdaptiveStim Technology Primary cell neurostimulator
Advice regarding the use of the device. HPRA Ref: V50879
Medtronic Inc.
Percept PC BrainSense
Advice regarding the use of the device. HPRA Ref: V50881
Medtronic Inc.
Cobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems
Advice regarding a software upgrade. HPRA Ref: V51008
Medtronic Inc.
SelectSite C304-HIS Deflectable Catheter System
Advice regarding a device removal. HPRA Ref: V51137
Mölnlycke
Mölnlycke® Procedure Trays
Advice regarding a device removal. HPRA Ref: V51026
Radiometer Medical ApS
PICO50 Arterial Blood Sampler
Advice regarding a device removal. HPRA Ref: V50961
Respironics California, LLC
V60/V60 Plus/V680 Ventilator
Advice regarding the use of the device. HPRA Ref: V50696
Siemens Healthcare Diagnostics Inc
Atellica® CH 930 Analyzer with Gamma-Glutamyl Transferase (GGT) Reagent
Advice regarding the use of the device. HPRA Ref: V45228
Siemens Healthcare GmbH
AXIOM Sensis XP / Sensis / Sensis Lite
Advice regarding a software upgrade. HPRA Ref: V51024
Siemens Healthcare GmbH
ARTIS icono
Advice regarding the use of the device. HPRA Ref: V50981
Sirona Dental Systems GmbH
Teneo
Advice regarding a device modification. HPRA Ref: V50916
Smiths Medical ASD, Inc.
Medfusion® 3500 and 4000 Syringe Infusion Pumps
Advice regarding a software upgrade. HPRA Ref: V50843
Sol-Millennium Medical, Inc.
SOL-M™ Blunt Fill Needle
Advice regarding a device removal. HPRA Ref: V50888
Umano Medical
ook snow
Advice regarding a software upgrade. HPRA Ref: V51037
UROMED Kurt Drews KG
UROMED disposable catheters
Advice regarding a device removal. HPRA Ref: V51101
Waters Corporation
NeoLynx and IonLynx software
Advice regarding the use of the device. HPRA Ref: V51027
XVIVO Perfusion AB
XVIVO Organ Chamber
Advice regarding the use of the device. HPRA Ref: V50990
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Date Printed: 19/04/2024