My HPRA: Register

Summary of Field Safety Notices- December 2022

Notice type: 3rd Party Publications

Date: 06/01/2023

  

Further Information:
Molecular Diagnostics at Abbott
Alinity M System
Advice regarding the use of the device. HPRA Ref: V53604


The Anspach Effort, Inc.
ANSPACH™ EMAX™ 2 Plus/EG1™ Electric Systems-Craniotome Attachments
Advice regarding the use of the device. HPRA Ref: V53543


Siemens Healthcare GmbH
Artis zee / Q / Q.zen with software version VD12A
Advice regarding the use of the device. HPRA Ref: V53634


Siemens Healthineers
AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200, AXIOM Luminos Agile, Luminos Agile Max, AXIOM Luminos dRF, Luminos dRF Max, and LUMINOS Lotus Max systems
Advice regarding a device modification. HPRA Ref: V53513

  
Endo-Flex
Biopsy Forceps SU
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53636


DePuy Ireland U.C.
BIOSTOP™ G Bioresorbable Cement Restrictor
Advice regarding a device removal. HPRA Ref: V53502


Smiths Medical
CADD™ Infusion System Infusion Sets for use with CADD pumps
Advice regarding the use of the device. HPRA Ref: V53605


Integra Lifesciences Production Corporation
Codman® Surgical Patties XRAY 1/2x1/2-200
Advice regarding a device removal. HPRA Ref: V53521


Decon Wheel AB
Controller of the drive unit E-Walk.
Advice regarding a device modification. HPRA Ref: V53486


Malvestio SPA
DELTA4 series electric bed with scales
Advice regarding a software upgrade. HPRA Ref: V53523


Philips Efficia 
External Paddles / Efficia Pads Adapter Cable
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53680


EPOCAL
epoc Host 2 and epoc NXS Host             
Advice regarding a software upgrade. HPRA Ref: V53572


Vascular Solutions
Expro Elite Snare
Advice regarding a device removal. HPRA Ref: V53669


Maquet Critical Care AB
Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
Advice regarding a software upgrade. HPRA Ref: V53655


Lina Medical Aps
LiNA Librata
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53619


Medtronic
Medtronic Evolut™ PRO+ 34mm Transcatheter Aortic Valve
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53515


VYGON GmbH
Multiocath2
Advice regarding a device removal. HPRA Ref: V53591


Intersurgical
Neonatal, Nasal Cannula with Curved Prongs and Tube, 2.1m
Advice regarding a device removal. HPRA Ref: V53391


Zimmer Biomet
NexGen® Option Stemmed Tibial Component
Advice regarding a device removal. HPRA Ref: V53545


Boston Scientific Corporation
ORISE™ Gel Submucosal Lifting Agent
Advice regarding a device removal. HPRA Ref: V53620


Phadia AB
Phadia 200
Advice regarding a software upgrade. HPRA Ref: V53500


Randox
Randox Specific Protein Control Levels 1-3     
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53357


Rayner Intraocular Lenses Limited
RayOne EMV
Advice regarding the use of the device. HPRA Ref: V53559


Spiegelberg GmbH & Co.KG
Silverline® Ventricular Probe 8F” (SND13.1.14), “Silverline® Ventricular Probe 10F” (SND13.1.15), “True Tunneling Intraventricular Probe 7F” (SND13.1.13TT), “True Tunneling Intraventricular Probe 9F” (SND13.1.13XLTT), “Probe 3PN with Trocar
Advice regarding the use of the device. HPRA Ref: V53574


Thermofisher
TaqPath COVID-19 HT Kit
Advice regarding a software upgrade. HPRA Ref: V52773


Osypka AG Medizintechnik
"VACSIII 22x40 Percutaneous Transluminal Valvuloplasty Catheter, YA 32240, LOT P351784-06
VACSIII 24x40 Percutaneous Transluminal Valvuloplasty Catheter, YA 32440, LOT P351384-05"
Advice regarding a device removal. HPRA Ref: V53529


Teleflex
various single-use endotracheal tubes
Advice regarding a device removal. HPRA Ref: V53581


Lohmann & Rauscher International GmbH & Co. KG
Vliwaktiv® Absorbent Activated Charcoal Dressing
Advice regarding a device removal. HPRA Ref: V53386


Vacsax Limited
Vommax Emesis bag
Advice regarding the use of the device. HPRA Ref: V53703


Baxter Healthcare SA
Y-Type Solution or blood administration set, Y-Type Blood/Solution Infusion Set with Interlink
Advice regarding a device removal. HPRA Ref: V53501
 

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