My HPRA: Register

Summary of Field Safety Notice – April 2017

Notice type: 3rd Party Publications

Date: 03/05/2017

  

Further Information:
Abbott  
ARCHITECT SHBG Reagent Kits
Advice regarding a device removal. HPRA Ref: V31617

Abbott (St. Jude Medical)
Merlin @Home Transmitter
Advice regarding a software upgrade. HPRA Ref: V31410

Abbott Vascular
Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Systems
Advice regarding a device removal. HPRA Ref: V31338

Advanced Medical Solutions
LiquiBand® FIX8™
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31243

AMO Uppsala AB
Healon, Healon GV, Healon 5 Pro, Healon Pro
Advice regarding a device removal. HPRA Ref: V31598

Arrow International Inc. / Teleflex Medical
ARROW® Kits with BD Eclipse™ Needles
Advice regarding the use of the device. HPRA Ref: V31532

Arthrex INC
Arthrex Swivelocks® SP Suture Anchor
Advice regarding a device removal. HPRA Ref: V31563

Beckman Coulter
Access BR Monitor
Advice regarding the use of the device. HPRA Ref: V31625

Beckman Coulter
Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
Advice regarding the use of the device. HPRA Ref: V31626

BES
Stealth Ultra Sub-Occipital Head Pad - Small and Medium
Advice regarding a device removal. HPRA Ref: V31585

BioMérieux Inc
ETEST® ETP32 (Ertapenem)
Advice regarding the use of the device. HPRA Ref: V31566

BioMérieux Inc
VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards
Advice regarding the use of the device. HPRA Ref: V31635

Bracco Engineering
CT Exprès Contrast Injection System, Temperature Maintainer Model
Advice regarding a device removal. HPRA Ref: V31468

Cadiotek
Physiologic Monitoring Systems
Advice regarding a software upgrade. HPRA Ref: V31582

Cardinal Health
Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems
Advice regarding a device removal. HPRA Ref: V31705

CareFusion
Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps and Asena™ GS, GH, CC, TIVA, PK Syringe Pumps
Advice regarding a device modification. HPRA Ref: V30350

Cook Incorporated
Pereyra Ligature Carrier, Pereyra-Raz Ligature Carrier '75, Stamey Needle
Advice regarding a device removal. HPRA Ref: V31403

Cook Incorporated
Stamey Needle, Clarke-Reich Laparoscopic Knot Push, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ‘75, Pereyra-Raz Ligature Carrier
Advice regarding a device removal. HPRA Ref: V31621

Cook Medical
TriForce™ Peripheral Crossing Set
Advice regarding a device removal. HPRA Ref: V30861

Cook Medical Europe
Bush DL™ Ureteral Illuminating Catheter Set / Bush SL™ Ureteral Illuminating Catheter Set
Advice regarding a device removal. HPRA Ref: V31158

Dexcom
G4 Platinum and G5 Mobile receiver
Advice regarding a device removal. HPRA Ref: V30691

IBA Dosimetry GmbH
Stealth Chamber
Advice regarding the use of the device. HPRA Ref: V31678

Karma Mobility Limited
Karma Flexx HD
Advice regarding a device modification. HPRA Ref: V30387

Liva Nova PLC
Ovatio, Paradym, Paradym RF, Paradym 2 and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
Advice regarding the use of the device. HPRA Ref: V31543

Medtronic
SynchroMed® II Implantable Drug Infusion Pump
Advice regarding the use of the device. HPRA Ref: V31580

Mercian
Sterile Caspar Distraction Screws
Advice regarding a device removal. HPRA Ref: V31645

Miele
PG 8527, PG 8528, PG 8535, PG 8536 Washer/Disinfectors
Advice regarding the use of the device. HPRA Ref: V31578

Natus
neoBLUE LED Phototherapy Systems
Advice regarding a device modification. HPRA Ref: V31558

Newport Medical Instruments
Newport™ HT70 and Newport™HT70 Plus Ventilators
Advice regarding a software upgrade. HPRA Ref: V31500

Nihon Kohden Corp
Life Scope G9
Advice regarding a software upgrade. HPRA Ref: V31394

Ossur Hf
Halo Vest/Lil Angel Halo Vest.
Advice regarding the use of the device. HPRA Ref: V31557

Shenzhen Mindray Bio-Medical Electronic Co. Limited 
Beneview T1 Patient Monitor
Advice regarding a device modification. HPRA Ref: V31628

Siemens Healthcare 
RAPIDPoint® 500 Systems
Advice regarding a software upgrade. HPRA Ref: V31424

Siemens Healthcare 
RAPID Point 500 Blood Gas Analyzer
Advice regarding a software upgrade. HPRA Ref: V31554

Siemens Healthcare 
Sensis System FSN 1
Sensis System FSN 2 
Advice regarding the use of the device. HPRa Ref: V31564

Smirthwaite Ltd
Bath Chairs and Bath Corner Chairs
Advice regarding a device modification. HPRA Ref: V31589

Stryker
LFIT™ Anatomic CoCr V40™ Femoral Heads
Advice regarding the use of the device. HPRA Ref: V29355

Stryker
Standard Lag Screw Omega
Advice regarding a device removal. HPRA Ref: V31597

Waters Corporation
ACQUITY UPLC Sample Organizer
Advice regarding a device modification. HPRA Ref: V31531
 

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