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Summary of Field Safety Notices - January 2021
Notice type:
3rd Party Publications
Date:
02/02/2021
Further Information:
Summary of Field Safety Notices - January 2021
Baxter
Cartridge Single Needle, Artiset HD DNL HC, Artiset Prepost, Cartridge with Hemoscan, Artiset HD SN HC, Cartridge Extended Patient Lines,
Cartridge Ext/ Patient Lines + Infusion, Cartridge Standard, Cartridge Low Weight, Cartridge Low Weight Low Volume, Physioset HD DNL HC, Physioset Prepost - Acknowledgement
Advice regarding the use of the device. HPRA Ref: V45554
Cartridge Single Needle, Artiset HD DNL HC, Artiset Prepost, Cartridge with Hemoscan, Artiset HD SN HC, Cartridge Extended Patient Lines,
Cartridge Ext/ Patient Lines + Infusion, Cartridge Standard, Cartridge Low Weight, Cartridge Low Weight Low Volume, Physioset HD DNL HC, Physioset Prepost
Advice regarding the use of the device. HPRA Ref: V45554
Baxter
PrisMax, V2, ROW
Advice regarding the use of the device. HPRA Ref: V45593
PrisMax, V2, ROW
Advice regarding a device removal. HPRA Ref: V45588
Baxter Healthcare SA
EVO IQ Large Volumetric Pump
Advice regarding a software upgrade. HPRA Ref: V45642
BD/CME
T34 Ambulatory syringe pump
Advice regarding a device removal. HPRA Ref: V42655
BEMER International AG
BEMER Classic and Pro therapy systems (Art. No. 410200, Art. No. 420200, Art. No. 410100, Art. No. 420100)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45402
Boston Scientific
Single-Use Polypectomy Snares: Captivator, Captivator II, Captiflex and Sensation
Advice regarding a device removal. HPRA Ref: V45572
Draeger Medical Systems, Inc.
Infinity Acute Care System (M540)
Advice regarding a software upgrade. HPRA Ref: V45530
Fannin Ltd.
MUELLER HINTON AGAR + 5% BLOOD & 20mg/L NAD (4mm) (EUCAST)
Advice regarding a device removal. HPRA Ref: V45601
GE Healthcare
Revolution Apex, Revolution CT
Advice regarding a device modification. HPRA Ref: V45570
Haemonetics
BloodTrack® Software Version 4.12.0
Advice regarding a software upgrade. HPRA Ref: V45600
Hillrom
Multirall 200
Advice regarding a device modification. HPRA Ref: V45406
Intersurgical Complete Respitory Systems
CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M
Advice regarding a device removal. HPRA Ref: V45468
Invacare
Invacare Perfecto2 V Oxygen Concentrator (Model Number: IRC5PO2VAW)
Advice regarding a device modification. HPRA Ref: V45529
Laboratoire Huckert's International
UMONIUM38 Medical Spray
Advice regarding a device removal. HPRA Ref: V45655
Maquet Cardiopulmonary GmbH
Customised Tubing Sets for use in extracorporeal circulation
Advice regarding the use of the device. HPRA Ref: V45623
Maquet Critical Care AB
SoKINOX/SERViNO NO delivery and monitoring systems
Advice regarding a device modification. HPRA Ref: V45621
MedCom GmbH
BiopSee, Version 3.2 Build 1, image fusion and navigated biopsy
Advice regarding a device modification. HPRA Ref: V44656
NIHON KOHDEN Corporation
NIHON KOHDEN Multiple Patient Receivers ORG-9100K
Advice regarding a software upgrade. HPRA Ref: V45594
NuVasive Specialized Orthopaedics
PRECICE Limb Lengthening System- All iterations
Advice regarding the use of the device. HPRA Ref: V45559
Olympus Medical Systems Corporation
Various endotherapy devices
Advice regarding a device removal. HPRA Ref: V45568
Ortho Clinical Diagnostics
ORTHO VISION® and ORTHO VISION® Max Analyzer Software Versions 5.12.8 and 5.13.0: Pipetting Error
Advice regarding a software upgrade. HPRA Ref: V45475
Philips
All EPIQ Systems (models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C,
EPIQ 7W, EPIQ CVx & EPIQ CVxi) shipped between 1/16/2019 and 10/22/2020.
Advice regarding the use of the device. HPRA Ref: V45589
Roche Diagnostics GmbH
9180 Electrolyte Analyzer
Advice regarding the use of the device. HPRA Ref: V45476
Siemens Healthcare Diagnostics Manufacturing Ltd
Atellica IM 1300 and IM 1600 Analyzers - Updated FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43722
WEINMANN Emergency Medical Technology GmbH
MEDUMAT Standard²
Advice regarding a device modification. HPRA Ref: V45633
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Date Printed: 28/01/2023