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Summary of Field Safety Notices - August 2020

Notice type: 3rd Party Publications

Date: 02/09/2020

  

Further Information:
Summary of Field Safety Notices - August 2020

Abbott
HeartMate 3TM Left Ventricular Assist System (LVAS) Kit
Advice regarding a device modification. HPRA Ref: V42322

Arex
Ligamentotaxor
Advice regarding the use of the device. HPRA Ref: V44644

ArthroCare Corporation
Speedstitch suturing needle
Advice regarding a device removal. HPRA Ref: V44602

Boston Scientific
Imager™ 5F II Angiographic Catheter
Advice regarding a device removal. HPRA Ref: V44430

GE Healthcare
"CT HiSpeed Series, CT ProSpeed Series, CT BrightSpeed Series, CT LightSpeed Series, Brivo CT series, Optima CT Series, Discovery CT Series
Revolution ACT, HD, GSI, EVO, Discovery ST, STE, VCT Discovery (560, 600, 610, 710), PET Optima (560, 560FX), Discovery IQ, 
Discovery MI, MI-DR, NM/CT Discovery (670, 870, 570c), NM/CT (860, 850)" - Customer Letter
Advice regarding the use of the device. HPRA Ref: V38359

"CT HiSpeed Series, CT ProSpeed Series, CT BrightSpeed Series, CT LightSpeed Series, Brivo CT series, Optima CT Series, Discovery CT Series
Revolution ACT, HD, GSI, EVO, Discovery ST, STE, VCT Discovery (560, 600, 610, 710), PET Optima (560, 560FX), Discovery IQ, 
Discovery MI, MI-DR, NM/CT Discovery (670, 870, 570c), NM/CT (860, 850)" - IFU Addendum
Advice regarding the use of the device. HPRA Ref: V38359

Getinge / Datascope / Maquet
Intra-Aortic Balloon Catheter
Advice regarding a device removal. HPRA Ref: V44528

Globus Medical
ALTERA Intervertebral disc spacer components
Advice regarding a device removal. HPRA Ref: V44609

Leckey
MyWay harness
Advice regarding a device modification. HPRA Ref: V42994

Life Technologies Corporation, a part of Thermo Fisher Scientific
TaqPath™ COVID-19 CE-IVD Interpretive Software
Advice regarding a software upgrade. HPRA Ref: V44413

Maquet Cardiopulmonary GmbH
Heater-Cooler Unit HCU 40
Advice regarding a device modification. HPRA Ref: V44559

Medline
Sterile Procedure Trays containing Allmed XR gauze swabs with XR Threads
Advice regarding the use of the device. HPRA Ref: V44713

Medtronic
Medtronic IPGs/CRTs/ICDs and Carelink
Advice regarding a software upgrade. HPRA Ref: V41657

Covidien Endo GIA™ Auto Suture™ universal articulating loading units
Advice regarding a device removal. HPRA Ref: V44521

NOUVAG AG
Motor System MD11, Moto System MD30
Advice regarding a device removal. HPRA Ref: V44579

Ortho Clinical Diagnostics
ORTHO VISION and VISION Max Analyzers
Advice regarding the use of the device. HPRA Ref: V44591

Randox Laboratories Ltd.
Randox Soluble Transferrin Receptors Cal & Control
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44396

Roche Diagnostics GmbH
Elecsys Anti-TPO
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44491

Siemens
Symbia S and Symbia T systems
Advice regarding a device modification. HPRA Ref: V44700

Smiths Medical ASD, Inc.
Medfusion 3500 and 4000 Syringe Pumps
Advice regarding the use of the device. HPRA Ref: V44636

Stryker
LIFEPAK® 15 Monitor/Defibrillator
Advice regarding the use of the device. HPRA Ref: V42615

TriMedika
TriTemp Non-contact Infrared Thermometer
Advice regarding the use of the device. HPRA Ref: V44395

William Cook Europe
Zenith Alpha Abdominal Endovascular Graft
Advice regarding a device removal. HPRA Ref: V44542

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