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 Notices - December 2020
Notice type:
3rd Party Publications
Date:
04/01/2021
Further Information:
Summary of Field Safety Notices - December 2020
Arjo
Minstrel - Patient Lift with Scale
Advice regarding a device modification. HPRA Ref: V45411
Baxter Healthcare SA
One-Link Non-DEHP Y-Type Microbore Catheter Extension Set
Advice regarding a device removal. HPRA Ref: V45488
Bioventus, LLC
EXOGEN Ultrasound Gel
Advice regarding a device removal. HPRA Ref: V45474
Boston Scientific
Hot Axios Stent Electrocautery Enhanced Delivery System
Advice regarding a device removal. HPRA Ref: V45243
EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD - Updated FSN
Advice regarding the use of the device. HPRA Ref: V41307
EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD
Advice regarding the use of the device. HPRA Ref: V45329
EMBLEM™ S-ICD Subcutaneous Electrode (Lead)
Advice regarding the use of the device. HPRA Ref: V45338
Carl Zeiss Meditec AG
ZEISS IOLMaster 700
Advice regarding a software upgrade. HPRA Ref: V45405
Carl Zeiss Meditec AG (JENA)
VISULENS 550 digital lensmeter
Advice regarding a device modification. HPRA Ref: V44616
Depuy
P
innacle Hip System - Apex Hole Eliminator
Advice regarding the use of the device. HPRA Ref: V45469
Dexcom
Dexcom G6 Sensor
Advice regarding the use of the device. HPRA Ref: V45339
DiaMed GmbH
Bio-Rad products: ID-Dia (Diego) Positive, ID-DiaCell SF, ID-DiaCell Pool, ID-DiaCell ABO*/I-II, ID-DiaCell ABO*/I-II-III,
ID-DiaScreen I-II-III-IV-VP-VIP, ID-DiaCell I-II, ID-DiaPanel, ID-DiaCell I-II-III, ID-DiaScreen I-II-III-IV, ID-DiaCell I-II-III Asia,
ID-DiaScreen Prophylax, ID-DiaPanel Plus 6, ID-DiaCell ABO*
Advice regarding the use of the device. HPRA Ref: V45500
Fannin Ltd
Chocolate Agar Slopes
Advice regarding the use of the device. HPRA Ref: V45327
Maquet Cardiopulmonary GmbH
Combination of Pediatric Venous Hardshell Cardiotomy Reservoir with QUADROX-I Pediatric Oxygenator Pediatric Venous Hardshell Cardiotomy Reservoir
Advice regarding a device removal. HPRA Ref: V45448
Medtronic
"CareLink™ Personal v14.1a (MMT-7333) using CareLink™ uploader (ACC-7350)
CareLink™ system v3.1a (MMT-7350) using CareLink™ uploader (ACC-7350)"
Advice regarding a software upgrade. HPRA Ref: V45365
Medtronic
"CareLink™ Personal v14.1a (MMT-7333) using CareLink™ uploader (ACC-7350)
CareLink™ system v3.1a (MMT-7350) using CareLink™ uploader (ACC-7350)" - FSN 1
Advice regarding a software upgrade. HPRA Ref: V45365
Medtronic Inc
Delta Valve, ventriculoperitoneal/ atrial shunt valve (Performance levels 1.0, 1.5, 2.0)
Advice regarding a device removal. HPRA Ref: V45413
Model A710 Intellis™ Software Application
Advice regarding a software upgrade. HPRA Ref: V45472
Phadia AB/Thermo Fisher Scientific
EliA dsDNA Well
Advice regarding a device removal. HPRA Ref: V45379
Philips Healthcare
Philips JETStream WorkSpace software version 2 and later
Advice regarding the use of the device. HPRA Ref: V45322
Philips Ultrasound Inc
Philips-EPIQ Ultrasound system
Advice regarding a software upgrade. HPRA Ref: V45507
Radiometer Medical ApS
AQT90 FLEX Analyzers
Advice regarding the use of the device. HPRA Ref: V45363
Remel Inc. (Thermofisher Scientific)
Remel BactiDrop Potassium Hydroxide (10%)
Advice regarding a device removal. HPRA Ref: V45420
SD Biosensor
SARS-CoV-2 Rapid Antigen Test
Advice regarding a device removal. HPRA Ref: V45208
Siemens Healthcare Diagnostics Inc.
Atellica CH 930 Reaction Cuvette Segment - FSN 5
Advice regarding the use of the device. HPRA Ref: V42624
Siemens Healthineers
Artis zee/Q/Q.zen systems
Advice regarding a software upgrade. HPRA Ref: V45037
Atellica IM 1300/1600 and CH 930 Analyzers
Advice regarding a software upgrade. HPRA Ref: V45297
IMMULITE/IMMULITE 1000 Estradiol
Advice regarding the use of the device. HPRA Ref: V42835
Smiths Medical
Portex Loss Of Resistance Device
Advice regarding a device removal. HPRA Ref: V45340
Steris
Medisafe Distal Duck Kit and Duck Bag (Humidity Pack)
Advice regarding a device removal. HPRA Ref: V45232
STERIS Canada ULC
Reliance Vision Single Chamber Washer Disinfector
Advice regarding a device modification. HPRA Ref: V45235
Stryker / Medela
AXS Universal Aspiration Tubing
Advice regarding a device removal. HPRA Ref: V45337
The Binding Site
Optilite Freelite Kappa Free Kits
Advice regarding the use of the device. HPRA Ref: V45315
« Back
Date Printed: 28/03/2024