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Summary of Field Safety Notices - June 2024
Notice type:
3rd Party Publications
Date:
04/07/2024
Further Information:
Abbott Diagnostics Technologies AS
Afinion 2
Advice regarding the use of the device, HPRA Reference CRN00FF4Z
Abbott Diagnostics Technologies AS
Afinion HbA1c
Advice regarding the use of the device, HPRA Reference CRN00FGM8
Abbott Medical
2nd Generation CentriMag Primary Console
Advice regarding the use of the device, HPRA Reference CRN00FFKY
Abbott Neuromodulation
Proclaim™, Proclaim™ XR, and Proclaim™ Elite SCS System, Proclaim™ DRG Neurostimulation System
Advice regarding the use of the device, HPRA Reference CRN00FFY5
Abbott Neuromodulation
Infinity™ DBS System
Advice regarding the use of the device, HPRA Reference CRN00FFY8
ArcRoyal uc, an Owens & Minor Company
CPT 1196 containing MONOCRYL™ Plus Sutures
Advice regarding a device removal, HPRA Reference CRN00FGNX
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
Advice regarding the use of the device, HPRA Reference CRN00FFMF
Beckman Coulter Ireland Inc.
AU IgM (Immunoglobulin M)
Advice regarding the use of the device, HPRA Reference CRN00FF3P
Becton, Dickinson and Company
BD Sensi-Disc
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00F0MS
Biocartis
IdyllaTM EGFR Mutation Test
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00FF2Z
bioMérieux UK Ltd
BioFire BCID2 Panel
Advice regarding the use of the device, HPRA Reference CRN00FG5M
Boston Scientific Corporation
Capio™ SLIM Suture Capturing Device
Advice regarding a device removal, HPRA Reference CRN00FH3M
Cardiac Pacemaker Inc
INGENIO™, VITALIO™, and ADVANTIO™ dual chamber (DR) extended life (EL) pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Advice regarding the use of the device, HPRA Reference V46745
GE Healthcare/GE Medical Systems
Various SIGNA/Discovery/Optima/Brivo MR systems
Advice regarding the use of the device, HPRA Reference CRN00FGTF
Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
Everest Bipolar Cutting Forceps
Advice regarding a device removal, HPRA Reference CRN00FHMZ
Haemotronic S.p.A
Aqualine, Aqualine S, Aqualine RCA, Aqualine D
Advice regarding the use of the device, HPRA Reference CRN00FFW5
Hologic, Inc.
Horizon DXA System
Advice regarding the use of the device, HPRA Reference CRN00FGRT
Immucor, Inc.
Panoscreen I and II
Advice regarding the use of the device, HPRA Reference CRN00FG4K
Immucor, Inc.
Panocell®-10
Advice regarding the use of the device, HPRA Reference CRN00FGN8
Inspiration Healthcare
SLE6000 Infant ventilator
Advice regarding a device modification, HPRA Reference CRN00FH65
LimaCorporate S.p.A.
Discovery Humeral Stems
Advice regarding the use of the device, HPRA Reference CRN00FG88
Lorne Laboratories Ltd.
Papenzyme-plus
Advice regarding a device removal, HPRA Reference CRN00FGZJ
Löwenstein Medical SE & Co. KG
Leoni plus HFO
Advice regarding the use of the device, HPRA Reference CRN00FH2W
LSO Medical
Ringlight Fiber
Advice regarding the use of the device, HPRA Reference CRN00FHD2
LumiraDx
LumiraDx Platform Instrument
Advice regarding the use of the device, HPRA Reference CRN00FF12
Maquet Cardiovascular, LLC/Getinge USA
Vasoview Hemopro, Vasoview Hemopro 2
Advice regarding the use of the device, HPRA Reference CRN00FGS2
Medtronic, Inc.
LINQ™II Insertable Cardiac Monitor
Advice regarding a device removal, HPRA Reference CRN00DXW0
Medtronics
Puritan Bennett 500 series ventilators
Advice regarding the use of the device, HPRA Reference CRN00FGGS
Megadyne Medical Products, Inc.
MEGADYNE™ MEGA SOFT™ and MEGA 2000™ Reusable Patient Return Electrodes
Advice regarding the use of the device, HPRA Reference CRN00FH4C
Olympus Medical Systems Corporation
HD Lightweight Pendulum Camera Head
Advice regarding a device modification, HPRA Reference CRN00FG9T
Olympus Winter & Ibe GmbH
ESG-410 electrosurgical generator
Advice regarding a device modification, HPRA Reference CRN00FH47
Philips Healthcare
SENSE XL Torso coil (1.5T and 3.0T)
Advice regarding the use of the device, HPRA Reference CRN00FFYG
Philips Healthcare (Suzhou) Co., Ltd
Multiva 1.5T
Advice regarding a device modification, HPRA Reference CRN00FFMV
Philips Respironics, Inc.
BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL
Advice regarding the use of the device, HPRA Reference CRN00FHCP
Radiometer Medical ApS
ABL800 Basic and ABL8XX FLEX analyzers
Advice regarding the use of the device, HPRA Reference CRN00FFJ5
Roche Diagnostics GmbH
cobas® EGFR Mutation Test v2
Advice regarding a software upgrade, HPRA Reference V47334
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
BeneHeart D1 Automated External Defibrillator
Advice regarding the use of the device, HPRA Reference CRN00FFKX
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
BeneHeart C Series Automated External Defibrillator
Advice regarding a software upgrade, HPRA Reference CRN00FG3Q
Smith & Nephew Orthopaedics
Surgical Guidance Software - Real Intelligence CORI
Advice regarding the use of the device, HPRA Reference CRN00FFS6
Smith Medical
Bivona® Neonatal/Pediatric and Adult Tracheostomy
Advice regarding a device removal, HPRA Reference CRN00FG42
Stryker Joint Replacement, Mahwah, USA
Exeter 2.5 I M Plug
Advice regarding a device removal, HPRA Reference CRN00F97L
Stryker Neurovascular
SYNCHRO Guidewires
Advice regarding the use of the device, HPRA Reference CRN00FFRC
Terumo BCT Inc
Spectra Optia Apheresis Syste FSN
Spectra Optia Apheresis Syste Customer Letter
Advice regarding the use of the device, HPRA Reference CRN00FFX5
Zimmer Inc.
CPT® Hip System Femoral Stem 12/14 Neck Taper
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00FHYP
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Date Printed: 17/09/2024