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Summary of Field Safety Notices - August 2019
Notice type:
3rd Party Publications
Date:
09/09/2019
Further Information:
Abbott Medical
CentriMag Motor
Advice regarding a device modification. HPRA Ref: V41253
ArjoHuntleigh AB
Concerto & Basic shower trolley
Advice regarding a device modification. HPRA Ref: V41119
Armstrong Medical
Catheter Mounts
Advice regarding a device removal. HPRA Ref: V41198
B Braun
Serofine Needles
Advice regarding a device removal. HPRA Ref: V40977
BD
T34 TM Ambulatory Syringe Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41133
Beckman Coulter
DxH800 and DxH600 and DxH 900 Hematology Analyzers
Advice regarding a software upgrade. HPRA Ref: V40182
Becton, Dickinson and Company
Alaris™ Gateway Workstation and Alaris™ Gateway Workstation Web Browser User Interface
Advice regarding a software upgrade. HPRA Ref: V40930
Becton, Dickinson and Company
BD FACSLyric™ Flow Cytometer - FSN
BD FACSLyric™ Flow Cytometer - Appendix
Advice regarding the use of the device. HPRA Ref: V41168
CooperSurgical, Inc.
TransWarmer Warming Infant Transport Mattress - FSN 1
TransWarmer Warming Infant Transport Mattress - Updated IFU
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40857
Covidien llc
BIS™ Vista and BIS™ View Monitoring Systems - FSN 1
BIS™ Vista and BIS™ View Monitoring Systems - FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V36610
DiaMed
IH-1000
Advice regarding a software upgrade. HPRA Ref: V41199
Fast Track Diagnostics
FTD Lyophilized products
Advice regarding a device modification. HPRA Ref: V40325
GE Healthcare
GE OEC Fluorostar Compact, GE OEC Fluorostar Series, GE OEC Fluorostar Compact D
Advice regarding a device modification. HPRA Ref: V41047
High Technology Products S.L.U
CoolTechnology (Cooltech)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V40986
Maquet
Heater Unit HU 35
Advice regarding a device modification. HPRA Ref: V41037
Medisoft S.A.
FeNO+
Advice regarding the use of the device. HPRA Ref: V40876
Medtronic
Medtronic Micra™ Delivery System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41131
Microtek Medical Ltd.
Intraoperative Probe Cover with Long Surgi-Tip
Advice regarding a device removal. HPRA Ref: V40853
Natus
Snap Leadwire & Gold Cup electrodes
Advice regarding a device removal. HPRA Ref: V41000
Olympus
MAJ-209 Single-Use Suction Valve
Advice regarding a device removal. HPRA Ref; V41235
Philips Medical Systems Nederland BV
Philips Azurion system with software version 1.2
Advice regarding a software upgrade. HPRA Ref: V40815
Philips Medical Systems Nederland BV
Philips Azurion with software version 1.2
Advice regarding a software upgrade. HPRA Ref: V40816
PROTEC GmbH & Co. KG
PROGNOST ES / PROGNOST FS / PROGNOST
SH ; 704x-5- ,70xx-5- , 7040-5- /
Advice regarding a device modification. HPRA Ref: V38824
Radiometer Medical APS
AQURE system
Advice regarding a software upgrade. HPRA Ref: V40827
Roche Diagnostics
cobas e801 AssayTip/AssayCup tray
Advice regarding a device removal. HPRA Ref: V41093
Rocket Medical
Rocket KCH Fetal Bladder Drain (R57405 _ R57405)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41079
Rocket Medical
Rocket® FBS Amnioscopes
Advice regarding the use of the device. HPRA Ref: V41088
Seca
Seca 402, Seca 403 cart
Advice regarding a device modification. HPRA Ref: V40905
Siemens Healthcare Diagnostics Manufacturing Ltd
Atellica CH 930 Analyzer
Advice regarding a software upgrade. HPRA Ref: V40920
Siemens Healthcare Diagnostics Manufacturing Ltd
Atellica CH 930 Analyzer
Advice regarding a software upgrade. HPRA Ref: V41126
Stryker / Howmedica
Triathlon
Advice regarding a device removal. HPRA Ref: V41122
Systagenix Wound Management Ltd
ADAPTIC™ Non-Adhering Dressing
Advice regarding a device removal. HPRA Ref: V40990
Teleflex / Vascular Solutions
TrapLiner Catheter
Advice regarding the use of the device. HPRA Ref: V41117
The Binding site
VaccZyme™ Human Anti-Haemophilus Influenzae type b
Advice regarding a device removal. HPRA Ref: V41130
Thermo Fisher Scientific
ThermoScientificTM OxoidTM Meropenem 32 M.I.C.E.
Advice regarding a device removal. HPRA Ref: V41111
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Date Printed: 26/04/2024