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Summary of Field Safety Notices - December 2020

Notice type: 3rd Party Publications

Date: 04/01/2021

  

Product name or type:

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
Pinnacle 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

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