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Summary of Field Safety Notice – February 2018
Notice type:
3rd Party Publications
Date:
07/03/2018
Further Information:
3M Health Care
3M™ Surgical Clipper Professional
Advice regarding a device removal. HPRA Ref: V34819
Aesculap AG
Doyen-Collin Mouth GAG 120mm
Advice regarding a device removal. HPRA Ref: V34538
ArjoHuntleigh AB
Arjo Quick Connect Scale used with Maxi Sky 2
Advice regarding a device modification. HPRA Ref: V34637
Becton, Dickinson & Company
BD OneFlow™ B-CLPD T1
Advice regarding the use of the device. HPRA Ref: V34995
Bovie Medical Corporation
Electrosurgical system
Advice regarding the use of the device. HPRA Ref: V34681
BrainLab AG
ExacTrac
Advice regarding a software upgrade. HPRA Ref: V34605
Cepheid
Xpert® GBS
Advice regarding the use of the device. HPRA Ref: V34266
Esaote S.p.a
MyLabTwice
Advice regarding a software upgrade. HPRA Ref: V34640
Establishment Labs
Motiva Implants: Silksurface, VelvetSurface
Advice regarding the use of the device. HPRA Ref: V34255
Fujifilm Corporation
FUJIFILM 7000 Video Processor
Advice regarding a software upgrade. HPRA Ref: V34801
GE Healthcare
CARESCAPE Central Station
Advice regarding a software upgrade. HPRA Ref: V34409
GE Healthcare
Centricity Universal Viewer
Advice regarding a software upgrade. HPRA Ref: V34680
Mast Group
AUGMENTIN 32mg/L PLATE, MPM-AUG32
Advice regarding the use of the device. HPRA Ref: V34976
Medtronic
Barrx™ 360 Express RFA Balloon Catheter, Model 64082
Advice regarding the use of the device. HPRA Ref: V34646
Olympus Medical Systems Corporation
URF-V2/URF-V2R flex. videoureteroscope
Advice regarding a device removal. HPRA Ref: V34455
Olympus Medical Systems Corporation
URF-P6/URF-P6R URETERO-RENOFIBERSCOPE
Advice regarding a device removal. HPRA Ref: V34497
Philips
Various Philips CT
Advice regarding a device modification. HPRA Ref: V35505
Philips Consumer Lifestyle B.V.
Philips Ear Thermometer DL8740 and Philips AVENT Smart Ear Thermometer SCH740
Advice regarding the use of the device. HPRA Ref: V34482
Philips Medical Systems
SureSigns VSi / SureSigns VS2+
Advice regarding changes/updates made to instructions for use. HPRA Ref: V34674
Physio-Control Inc. USA
LIFEPAK 20e defibrillator/monitor
Advice regarding a device modification. HPRA Ref: V34667
Randox
Liquid Cardiac Control - CQ5051 - 4144CK
Advice regarding a device modification. HPRA Ref: V34984
Randox
Lipase FSN
Lipase - Attachment 1
Lipase - Attachment 2
Lipase - Attachment 3
Lipase - Attachment 4
Lipase - Attachment 5
Advice regarding a device modification. HPRA Ref: V35046
Roche
cobas b 221 AutoQC scheduler
Advice regarding a software upgrade. HPRA Ref: V34814
Siemens Healthineers GmbH; Business Area Advanced Therapies
Artis systems with Artis table
Advice regarding a device modification. HPRA Ref: V34196
Smith & Nephew
Intertan 10S 10mm X 18cm 130D
Advice regarding a device removal. HPRA Ref: V34051
Smiths Medical
Medfusion® Syringe Pump, model series 3500 and 4000
Advice regarding a device removal. HPRA Ref: V34886
St Jude Medical
Nanostim™ Leadless Cardiac Pacemaker
Advice regarding the use of the device. HPRA Ref: V33936
Thermofisher
ThermoScientific™ Oxoid™ Mueller Hinton Broth
Advice regarding a device removal. HPRA Ref: V34815
Thermofisher
Thermo Scientific™ Remel™ R30166601 - Neisseria meningitidis Poly A-D & Thermo Scientific™ Remel™ R30167001 - Neisseria meningitidis Group D
Advice regarding a device removal. HPRA Ref: V35000
TRILUX Medical GmbH & Co.KG
Aurinio LED OR Luminaire
Advice regarding a device modification. HPRA Ref: V34547
Viricell
BORRELIA VIRCLIA® lgG MONOTEST
Advice regarding a device removal. HPRA Ref: V34739
XO Care A/S
XO 4 and XO Flex Unit
Advice regarding the use of the device. HPRA Ref: V34516
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Date Printed: 26/04/2024