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Summary of Field Safety Notices - November 2020
Notice type:
3rd Party Publications
Date:
03/12/2020
Further Information:
Abbott GmBH
ARCHITECT EBV VCA IgM Calibrator
Advice regarding a device removal. HPRA Ref: V45120
Baxter
Artis Haemodialysis System
Advice regarding the use of the device. HPRA Ref: V45241
Beckman Coulter, Inc.
Access Unconjugated Estriol
Advice regarding the use of the device. HPRA Ref: V44808
Becton Dickinson
Alaris™ GP and GP Guardrails, Alaris™ NEXUS GP
Advice regarding a device modification. HPRA Ref: V45172
AlarisTM GW and GW 800 Volumetric Pumps
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45204
Boston Scientific
LOTUS Edge Valve System
Advice regarding a device removal. HPRA Ref: V45188
Cardinal Health
Protexis Latex Micro Surgical Gloves
Advice regarding the use of the device. HPRA Ref: V45069
Cook Incorporated
Flexor Check-Flo Introducer, Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select)
Advice regarding a device removal. HPRA Ref: V45244
Evolutis SAS
Shoulder stems, Knees, Hip cup, Hip stem
Advice regarding a device modification. HPRA Ref: V45102
Fast-Track Diagnostics S.a.r.l.
Various FTD products
Advice regarding a device removal. HPRA Ref: V42435
GA Healthcare
Andorate Disposable Valve Set
Advice regarding a device removal. HPRA Ref: V45166
Galil Medical Ltd
Cryoablation needles
Advice regarding the use of the device. HPRA Ref: V45227
GE Medical Systems Information Technologies, Inc.
MAC VU360 Resting ECG Analysis System
Advice regarding a software upgrade. HPRA Ref: V45202
GS Medical
Robotic Sponge
Advice regarding the use of the device. HPRA Ref: V45109
IntelliVue Multi Measurement Server X2, IntelliVue MP2
IntelliVue Multi Measurement Server X2, IntelliVue MP2
Advice regarding a device modification. HPRA Ref: V45257
Karlstorz
Plastic Container for Sterilization
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45070
Laerdal
Laerdal Compact Suction Unit® 4 (LCSU® 4)
Advice regarding a device removal. HPRA Ref: V45098
Maquet Cardiopulmonary GmbH
HLS Set Advanced 5.0 or 7.0
Advice regarding a device removal. HPRA Ref: V45174
Medtronic
CareLink™ Personal v14.1a (MMT-7333) using CareLink™ reports v5.2b (ACC-7333)
CareLink™ system v3.1a (MMT-7350) using CareLink™ reports v5.2b (ACC-7333) - FSN
Advice regarding a software upgrade. HPRA Ref: V45112
CareLink™ Personal v14.1a (MMT-7333) using CareLink™ reports v5.2b (ACC-7333)
CareLink™ system v3.1a (MMT-7350) using CareLink™ reports v5.2b (ACC-7333) - FSN v2
Advice regarding a software upgrade. HPRA Ref: V45112
Cobalt™, Cobalt™ XT and Crome™ Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs)
Advice regarding a device removal. HPRA Ref: V45274
InterStim Percutaneous Extension - Updated FSN
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45009
InterStim Percutaneous Extension - Updated FSN attachment
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45009
Microbiologics, Inc.
KWIK-STIK, KWIK-STIK Plus and LYFO DISK
Advice regarding a device removal. HPRA Ref: V45157
Olympus
Ultrasound Endoscope
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45213
Philips
EPIQ & Affiniti Ultrasound Systems
Advice regarding the use of the device. HPRA Ref: V45162
Randox
Randox Magnesium (Mg), Xylidyl Blue, Colorimetric
Advice regarding a device removal. HPRA Ref: V45183
Roche Diagnostics
Various Cobas Products - FSN
Advice regarding the use of the device. HPRA Ref: V45304
Various Cobas Products - Attachment 1
Advice regarding the use of the device. HPRA Ref: V45304
Various Cobas Products - Attachment 2
Advice regarding the use of the device. HPRA Ref: V45304
Various Cobas Products - Attachment 3
Advice regarding the use of the device. HPRA Ref: V45304
Roche Molecular Systems
cobas z 480 analyzer
Advice regarding the use of the device. HPRA Ref: V45250
Siemens Healthcare Diagnostics Inc.
Atellica IM 1300 Analyzer, Atellica IM 1600
Advice regarding the use of the device. HPRA Ref: V45075
Atellica CH® Analyzer
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45099
Atellica® CH 930 Analyzer Gamma-Glutamyl Transferase (GGT) Reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45228
Siemens Healthineers
SOMATOM CT
Advice regarding a software upgrade. HPRA Ref: V45254
ARTIS pheno, ARTIS icono biplane, ARTIS icono floor
Advice regarding a software upgrade. HPRA Ref: V45251
Sis Medical
OPN NC PTCA Balloon
Advice regarding the use of the device. HPRA Ref: V45165
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Date Printed: 22/01/2021