Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Summary of Field Safety Notice – June 2017
Notice type:
3rd Party Publications
Date:
04/07/2017
Further Information:
Acandis GmbH & Co. KG
NeuroSpeed PTA Balloon Catheter
Advice regarding a device removal. HPRA Ref: V32197
AlterG, Inc
Anti-Gravity
Advice regarding a device modification. HPRA Ref: V32358
Angio Dynamics Inc.
Acculis Accu2i pMTA Applicator
Advice regarding a device removal. HPRA Ref: V32185
ArjoHuntleigh
FLOWTRON ACS900
Advice regarding a software upgrade. HPRA Ref: V32114
Atrium New Hampshire
Atrium Advanta V12 Balloon Expandable Covered Stent 7 mm x 22 mm x 120 cm
Advice regarding a device removal. HPRA Ref: V32123
Balt Extrusion
Microcatheter Sonic 1.5F
Advice regarding a device removal. HPRA Ref: V31807
Balt Extrusion
Microcatheter Sonic
Advice regarding the use of the device. HPRA Ref: V32278
Baxter
Claria Sharesource Platform
Advice regarding the use of the device. HPRA Ref: V32175
Baxter
AK 98, 230V, Bio
Advice regarding a device modification. HPRA Ref: V32209
Beckman Coulter
Synchron AQUA CAL Level 1
Advice regarding a device removal. HPRA Ref: V32070
Beckman Coulter
COULTER PrepPlus & PrepPlus 2
Advice regarding a device removal. HPRA Ref: V32111
Beckman Coulter
COULTER LH 750 Analyzer / COULTER LH 780 Analyzer / COULTER LH500 Analyzer / COULTER HmX CP Analyzer / COULTER HmX AL Analyzer
Advice regarding the use of the device. HPRA Ref: V32284
Beckman Coulter Ireland Inc.
DxH 500
Advice regarding a software upgrade. HPRA Ref: V31986
Biocompatibles UK Ltd. (BTG)
DC Bead™ and DC Bead M1™
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32213
Biomerieux
VITEK 2 Gram-Negative AST Cards
Advice regarding the use of the device. HPRA Ref: V32121
Boston Scientific
S-ICD Programmer
Advice regarding a software upgrade. HPRA Ref: V30497
Boston Scientific
S-ICD Memory Corruption - (S-ICD Systems: SQ-RX™ model 1010, EMBLEM™ model A209 and EMBLEM™ MRI model A219)
Advice regarding a software upgrade. HPRA Ref: V32265
CellaVision AB
DI-60
Advice regarding a software upgrade. HPRA Ref: V32359
Chalice Medical
Paratherm
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30535
Cook Medical
Vue Optic Visualization Source; Flexor Vue Deflecting Endoscopic System
Advice regarding the use of the device. HPRA Ref: V31755
Cook Medical
Zenith Alpha™ Thoracic Endovascular Graft
Advice regarding a device removal. HPRA Ref: V32326
Draeger Medical Systems Inc
Infinity Acute Care System (M540)
Advice regarding a device modification. HPRA Ref: V32108
Elekta
MOSAIQ
Advice regarding the use of the device. HPRA Ref: V32389
Endologix
AFX EndoVascular AAA System, with STRATA graft material
Advice regarding the review of patient results/patient recall/sample retesting isrequired. HPRA Ref: V32254
GE Healthcare
Infant Warmer System
Advice regarding a device modification. HPRA Ref: V32068
GE Healthcare
Centricity Critical Care (CCC, formerly known as Clinisoft)
Advice regarding a software upgrade. HPRA Ref: V32324
Hitachi High-Technologies Cooperation & Roche
PROBE SAMPLE - cobas c - FSN 1
PROBE SAMPLE - cobas c - Attachment 1
PROBE SAMPLE - cobas c - Attachment 2
PROBE SAMPLE - cobas c - Attachment 3
PROBE SAMPLE - cobas c - FSN 2
PROBE SAMPLE - cobas c - Attachment 4
Advice regarding a device removal. HPRA Ref: V31066
Hoya Corporation
Ultrasound Upper GI Videoscopes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32261
ICU Medical
Plum 360 Infusion Pump
Advice regarding a device modification. HPRA Ref: V32274
Intersurgical
BVM Manual Resuscitation Systems
Advice regarding the use of the device. HPRA Ref: V32113
Intuitive Surgical
da Vinci® Xi™ Surgical System
Advice regarding a device modification. HPRA Ref: V32145
Leica Biosystems
ASP6025 Tissue Processor
Advice regarding a device modification. HPRA Ref: V32151
LivaNova
Aortic Cannulae
Advice regarding a device removal. HPRA Ref: V32171
LivaNova
Model 105 Aspire HC® and 106 AspireSR® VNS Therapy® Generators
Advice regarding the use of the device. HPRA Ref: V32376
Maquet / Getinge
SoKinox/ServiNo
Advice regarding a software upgrade. HPRA Ref: V32397
Maquet / Getinge
Maquet/Datascope CS100i Intra-Aortic Balloon Pump (IABP); Maquet/Datascope CS100 Intra-Aortic Balloon Pump (IABP); Maquet/Datascope CS300 Intra-Aortic Balloon Pump (IABP)
Advice regarding a device modification. HPRA Ref: V32260
Medtronic Inc
11001G - DLP® Extension Line Adapters 20 in length; and various other devices
Advice regarding a device removal. HPRA Ref: V32323
NHSBT
Titration cell 1
Advice regarding a device removal. HPRA Ref: V32328
Philips
HeartStart MRx Monitor/Defibrillator
Advice regarding a device modification. HPRA Ref: V32172
Roche
Mixed sample results in immunochemistry modules
Advice regarding a software upgrade. HPRA ref: V32325
Sentinel Diagnostics
MULTIAGENT Creatinine (Enzymatic)
Advice regarding a device removal. HPRA Ref: V32039
Shimadzu
Rad Speed Series (Pro/CH-200/CH-200M)
Advice regarding a device modification. HPRA Ref: V31995
Siemens
Axiom Artis, Artis Zee, Q, and Q Zen systems.
Advice regarding a device modification. HPRA Ref: V32118
Siemens
Artis Systems, X-Workplace, Sensis and Arcadis Systems
Advice regarding a software upgrade. HPRA Ref: V32215
Siemens
Syngo Workflow MLR using Portal Radiologist
Advice regarding a software upgrade. HPRA Ref: V32384
Taizhou Xinkang Medical Material Co., Ltd
Wound dressing / NO.8, NO.9, NO.3
Advice regarding a device removal. HPRA Ref: V31604
Terumo Corporation
Radifocus Introducer II, Radifocus Introducer II M coat and Glidesheath Slender
Advice regarding a device removal. HPRA Ref: V32107
TOSHMedical
Aplio 500
Advice regarding a software upgrade. HPRA Ref: V32115
Trinity Biotech
Premier Buffer B Reagent
Advice regarding a device removal. HPRA Ref: V32110
UniSurge
Yellow Handled Sharp/Blunt Supasnip Scissors
Advice regarding a device removal. HPRA Ref: V31981
Wassenburg Medical B.V.
Wassenburg WD440 Endoscope Washer Disinfector
Advice regarding a software upgrade. HPRA Ref: V31054
Zimmer Biomet
Cementless Oxford Partial Knee Unicompartmental Knee Replacement System
Advice regarding the use of the device. HPRA Ref: V31252
Zimmer Biomet
Affixus Hip Fracture Nail
Advice regarding a device removal. HPRA Ref: V32144
Zimmer Biomet
Guidewire 70cm - FSN 1
Guidewire 70cm - FSN 2
Advice regarding a device removal. HPRA Ref: V32262
« Back
Date Printed: 17/04/2024