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Summary of Field Safety Notices - February 2020
Notice type:
3rd Party Publications
Date:
02/03/2020
Further Information:
Summary of Field Safety Notices - February 2020
Accriva Diagnostics Inc.
Hemochron Signature Elite
dvice regarding a software upgrade. HPRA Ref: V42820
Advanced Bionics
HiRes Ultra / HiRes Ultra 3D
Advice regarding a device removal. HPRA Ref: V42951
Baxter
Prismaflex System
Advice regarding the use of the device. HPRA Ref: V42953
BD
T34 TM and T34LTM (T60TM) Ambulatory Syringe Pumps
Advice regarding the use of the device. HPRA Ref: V42655
Biocartis
Idylla™ EGFR Mutation Test
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43006
BioFire Diagnostics
FilmArray® Blood Culture Identification (BCID) Panel
Advice regarding the use of the device. HPRA Ref: V42803
Boston Scientific Corporation
Imager II 5F Angiographic Catheters
Advice regarding a device removal. HPRA Ref: V42789
Breas
NIPPY 3+, Junior +, ST+ and S+
Advice regarding the use of the device. HPRA Ref: V42649
Cair LGL
Stopcock with Mobile Ring
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42932
Cardiac Science
Powerheart G3 Elite AED
Advice regarding a software upgrade. HPRA Ref: V42775
Dermosciences France
TCA 12, TCA 15, TCA 18, TCA 20
Advice regarding a device removal. HPRA Ref: V42799
Activa Peel, Mela Peel, Activa Peel Forte, Mela Peel Forte
Advice regarding a device removal. HPRA Ref: V42800
FCI S.A.S.
Purified silicon oil reference S5.7570, S5.7170, S5.7560 et S5.7160
Advice regarding a device removal. HPRA Ref: V42551
Heraeus Medical GmbH
Palamix Uno, Palamix Duo
Advice regarding the use of the device. HPRA Ref: V42844
James Leckey Design Ltd
MyWay Harness
Advice regarding a device modification. HPRA Ref: V42994
Nuvasive
MAGEC System
Advice regarding a device removal. HPRA Ref: V42982
Ormco Corporation
Snaplink Buccal Tube
Advice regarding the use of the device. HPRA Ref: V42755
Philips
Efficia DFM100
Advice regarding a device modification. HPRA Ref: V42698
Efficia Combined Cable/3 and 5 Leadsets (Efficia Combined Cable/Leadsets)
Advice regarding a device removal. HPRA Ref: V43021
IntelliVue TRx4841A and TRx4851A Telemetry Transceivers
Advice regarding a device removal. HPRA Ref: V43046
Qiagen GmbH
Rotor-Gene Q Software Version 2.3.4
Advice regarding a software upgrade. HPRA Ref: V42861
Randox Laboratories Limited
Chemistry QC Premium Plus
Advice regarding a device removal. HPRA Ref: V42899
Roche Diabetes Care GmbH
Accu-Chek Solo pump base
Advice regarding the use of the device. HPRA Ref: V41991
Schiller
Tempus LS
Advice regarding a device modification. HPRA Ref: V42878
Shanghai Kindly Enterprise Development Group Co Ltd
Alaris® Extension Sets, Low Sorbing (PE)
Advice regarding a device removal. HPRA Ref: V42826
Siemens
IMMULITE/IMMULITE 1000 Estradiol
Advice regarding the use of the device. HPRA Ref: V42835
Linear Accelerators
Advice regarding the use of the device. HPRA Ref: V42949
Artis zeego & Artis zee/Q./Q.zen
Advice regarding a software upgrade. HPRA Ref: V42950
Siemens Healthcare Diagnostics
Atellica IM 1300 and IM 1600 Analyzers
Advice regarding the use of the device. HPRA Ref: V42558
Clinitek Status +Analyzer with a Connect Platform
Advice regarding the use of the device. HPRA Ref: V42750
Atellica CH 930 Analyzer
Advice regarding a software upgrade. HPRA Ref: V43004
Siemens Healthcare Diagnostics Inc.
RAPIDLyte® Arterial Line Draw Sampler
Advice regarding a device removal. HPRA Ref: V42796
Atellica CH® Analyzer
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42893
Dimension® clinical chemistry system
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42893
Stago
STA Compact, STA Compact Max, STA-R Evolution, STA-R Max
Advice regarding a software upgrade. HPRA Ref: V42937
Vygon
Octopus
Advice regarding a device removal. HPRA Ref: V42919
Wassenburg Medical B.V
Wassenburg DRY320 Drying Cabinet For Flexible Endoscopes
Advice regarding a device modification. HPRA Ref: V42790
Wright Medical
MoPyc Radial Head Prosthesis Impactor
Advice regarding the use of the device. HPRA Ref: V42959
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Date Printed: 27/04/2024