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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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