Follow @TheHPRA
Contact us
Glossary
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety Notices
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our Role
Safety Information
Vigilance
Compliance
Reporting Safety Issues
Safety Notices
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
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
« Back
Date Printed: 24/05/2022