My HPRA: Register

Summary of Field Safety Notices- January 2023

Notice type: 3rd Party Publications

Date: 01/02/2023

  

Further Information:
Air Liquide Medical Systems
Monnal T60 Ventilators
Advice regarding a software upgrade. HPRA Ref: V53762


Avanos Medical Inc.
CORTRAK* 2 Enteral Access System (EAS)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V50968


B. Braun Medical Ltd.
Infusomat Space Transfusion Line
Advice regarding a device removal. HPRA Ref: V53797


B. Braun Medical Ltd.
Original Perfusor® Line
Advice regarding a device removal. HPRA Ref: V53860


Balanced Body, Inc.
Studio Reformer
Advice regarding the use of the device. HPRA Ref: V53719


Beckman Coulter
Access 2 Immunoassay Analyzer / Access 2 Immunoassay Analyzer, Refurbished / Access 2 Immunoassay Analyzer-Refurbished / Access 2 Section, DxC 600i Packaged.
Advice regarding the use of the device. HPRA Ref: V53924


Biomerieux
MUELLER HINTON E AGAR
Advice regarding the use of the device. HPRA Ref: V53925


CooperSurgical
NEO-fit™ Neonatal Endotracheal Tube Grip
Advice regarding a device removal. HPRA Ref: V53053


CooperSurgical
17G Wallace Single‐Lumen Oocyte Recovery Set
Advice regarding the use of the device. HPRA Ref: V53917


Covidien llc
Dermalon™ Monofilament Nylon sutures; Monosof™ Monofilament Nylon sutures; Novafil™ Monofilament Polybutester Suture; Sofsilk™ Coated Braided Silk Suture; Surgilon™ Braided Nylon suture; Surgidac™ Uncoated Braided Polyester suture; Surgipro™ Monofilament Polypropylene Sutures; Surgipro™ II Monofilament Polypropylene Sutures; Ti-Cron™ Coated Braided Polyester Suture
Advice regarding a device removal. HPRA Ref: V53329


Covidien llc
Tri-Staple™ 2.0 Black Intelligent Reload 60mm Extra Thick
Advice regarding a device removal. HPRA Ref: V53852


Datascope Corp. Getinge
MAQUET CARDIOSAVE Hybrid and MAQUET CARDIOSAVE Rescue
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53696


Drager
Infinity® CentralStation
Advice regarding a software upgrade. HPRA Ref: V53635


Drager
NovaStar plus, Nova Star TS Masks
Advice regarding the use of the device. HPRA Ref: V53809


FUJIFILM Irvine Scientific Inc
Oil for Embryo Culture
Advice regarding a device removal. HPRA Ref: V53868


GE Healthcare
Vivid i, Vivid q, Vivid S5, Vivid S6 Ultrasound
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53764


GE Medical Systems
Nuclear Medicine 600/800 series systems
Advice regarding the use of the device. HPRA Ref: V53715


GE Medical Systems Information Technologies, Inc.
B125P/B105P/B125M/B105M/B155M Patient Monitor
Advice regarding the use of the device. HPRA Ref: V53697


Ivor Shaw Ltd t/a Pennine Healthcare
Link Yankauer Sets and Suction Connecting Tubing
Advice regarding a device removal. HPRA Ref: V53916


Johnson & Johnson International
Coated  VICRYL™  PLUS  Antibacterial  suture
Advice regarding a device removal. HPRA Ref: V53733


Kitazato Corporation
Gamete Buffer
Advice regarding a device removal. HPRA Ref: V53883


Maquet Cardiopulmonary GmbH
PLS Set; HLS Set Advanced 5.0; HLS Set Advanced 7.0
Advice regarding the use of the device. HP~RA Ref: V52053


Maquet Cardiopulmonary GmbH
PLS Set; HLS Set Advanced 5.0; HLS Set Advanced 7.0
Advice regarding the use of the device. HPRA Ref: V53214


Medtronic Inc.
Vanta LT Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V52153


Medtronic Inc.
Vanta / Sequentia LT Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V52161


Medtronic Inc.
Vanta LT Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V53461


Molecular Diagnostics at Abbott
Alinity m HBV Amplification (AMP) Kit
Advice regarding the use of the device. HPRA Ref: V53863


Ortho Clinical Diagnostics
ORTHO® VISION and ORTHO® VISION Max Analyzers
Advice regarding the use of the device. HPRA Ref: V53712


Respironics LLC
Philips Respironics V680 Ventilator
Advice regarding a device removal. HPRA Ref: V53850


Roche Molecular Systems, Inc.
cobas® SARS-CoV-2 & Influenza A/B (catalogue number: 09233474190) for use on the cobas®  6800/8800  Systems
cobas® SARS-CoV-2 & Influenza A/B (catalogue number: 09446125190) for use on the cobas® 5800/6800/8800 Systems
cobas® Influenza A/B & RSV UC (catalogue number: 09233962190) for use  on the cobas® 6800/8800  Systems
Advice regarding the use of the device. HPRA Ref: V53624


Roche Molecular Systems, Inc.
Elecsys Troponin T hs
Advice regarding the use of the device. HPRA Ref: V53796


SCHILLER AG
AT-102 / AT-102 plus / AT-10 plus / AT-104 PC / AT-104 PC ErgoSpiro / MS-2007 / MS-2010 / MS-2015 / CS-200 / CS-200 ErgoSpiro
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53993


Schiller Medical
DEFIGARD Touch-7
Advice regarding a software upgrade. HPRA Ref: V53695


Serosep Limited
EntericBio Viral Panel 3
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53931


Siemens Healthcare Diagnostics
Atellica IM Folate
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53746


Siemens Healthcare Diagnostics
Atellica CH LDL Cholesterol Direct (DLDL) reagents, Atellica CH Total Protein II (TP) reagents, Atellica CH Triglycerides (Trig) reagents, Atellica CH Triglycerides_2 (Trig)_2 reagents)
Advice regarding the use of the device. HPRA Ref: V53912


Tracoe Medical GmbH
Tracoe Experc Dilation Set (REF 520), Tracoe Experc Sets Vario, Twist and Twist Plus
Advice regarding changes/updates made to instructions for use. HPRA Ref: V54004
 

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