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Summary of Field Safety Notices - September 2021
Notice type:
3rd Party Publications
Date:
04/10/2021
Further Information:
Summary of Field Safety Notices - September 2021
Abbott Molecular Inc
Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kit
Advice regarding the use of the device. HPRA Ref: V47379
Abbott USA
EnSite X Display Workstation
Advice regarding a software upgrade. HPRA Ref: V47523
Acumed LLC
Medium Ratcheting Driver Handles
Advice regarding a device removal. HPRA Ref: V47483
Advanced Surgical Concepts
PneumoLiner
Advice regarding a device removal. HPRA Ref: V47475
Aesculap AG
Bipolar Cup Trial Head
Advice regarding the use of the device. HPRA Ref: V47469
Agilent Technologies, Inc.
EnVision FLEX Hematoxylin (Link) Kit
Advice regarding a device removal. HPRA Ref: V47376
Baxter
Central Water Plant (CWP) 800 Systems
Advice regarding a device modification. HPRA Ref: V46354
Biodex Medical Systems Inc.
AtomLab™ 500 Dose Calibrator and AtomLab™ 500Plus Dose Calibrator
Advice regarding a software upgrade. HPRA Ref: V47485
bioMérieux SA
VIDAS® Immuno-Assays Multiple references
Advice regarding the use of the device. HPRA Ref: V47530
MYLA V4.7 software and MYLA V4.8 software
Advice regarding a software upgrade. HPRA Ref: V47455
Cook Medical
Single Lumen and Double Lumen Ovum Pick-Up Needles
Advice regarding the use of the device. HPRA Ref: V47302
Datascope Corp. Getinge
Cardiosave Intra-Aortic Balloon Pumps
Advice regarding the use of the device. HPRA Ref: V47429
Cardiosave Li-Ion Battery Pack
Advice regarding a device removal. HPRA Ref: V47505
Datex-Ohmeda, Inc.
Flow Sensors used in GE Healthcare / Datex-Ohmeda Anaesthesia Machines
Advice regarding the use of the device. HPRA Ref: V47358
Eden Innovations
DOC fixed and DOC mobile accessory of Philips HS1 defibrillator
Advice regarding a device removal. HPRA Ref: V42868
Elekta
Linear Accelerator
Advice regarding the use of the device. HPRA Ref: V47438
Getinge
Atrium Pneumostat Chest Drain Valve
Advice regarding the use of the device. HPRA Ref: V47354
Labratoire CCD
1ml IVF and AI Syringes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V42165
Medtronic
LINQ II Insertable Cardiac Monitor
Advice regarding the use of the device. HPRA Ref: V46738
Activa Clinician Programmer Application
Advice regarding a software upgrade. HPRA Ref: V47453
Medtronic Xomed Inc
Sterile Blade Single-Use Accessories - Updated FSN
Advice regarding a device removal. HPRA Ref: V47351
Microbiologics Inc.
HE™Synthetic Standard SARS-CoV-2 Process Control (Swab)
Advice regarding the use of the device. HPRA Ref: V47420
HE™Synthetic Standard SARS-CoV-2 Process Control (Pellet)
Advice regarding the use of the device. HPRA Ref: V47427
MILESTONE S.R.l.
SEALSAFE, llSSUESAFE PLUS
Advice regarding a device removal. HPRA Ref: V47363
OPHTEC BV
Artisan and Artiflex phakic intraocular lenses (PIOLs)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47470
Paradigm Spine GmbH
HPS 2.0™ Rod coupler ; HBI95527 / HBI95527
Advice regarding a device removal. HPRA Ref: V46476
Philips Ultrasound, Inc.
Philips EPIQ & Affiniti Ultrasound Systems
Advice regarding the use of the device. HPRA Ref: V47415
Roche Diagnostics GmbH
cobas c 503 TDM Vancomycin, Gentamicin, Phenytoin, Theophylline, Phenobarbital
Advice regarding a software upgrade. HPRA Ref: V46429
cobas® EGFR Mutation Test v2
Advice regarding the use of the device. HPRA Ref: V47334
Siemens Healthcare Diagnostics Limited
Atellica CH and ADVIA Urinary/Cerebrospinal Fluid - FSN 1
Advice regarding a software upgrade. HPRA Ref: V47435
Atellica CH and ADVIA Urinary/Cerebrospinal Fluid - FSN 2
Advice regarding a software upgrade. HPRA Ref: V47435
Smiths Medical
LEVEL 1® Fast Flow and Irrigation Fluid Warming Systems
Advice regarding the use of the device. HPRA Ref: V47220
Sunrise Medical
Zippie Voyage®
Advice regarding a device modification. HPRA Ref: V47228
The Spectranetics Corporation
Bridge® Occlusion Balloon
Advice regarding the use of the device. HPRA Ref: V47356
W.L Gore & Associates
GORE Cardioform Septal Occluder
Advice regarding a device removal. HPRA Ref: V47346
Welch Allyn Inc.
ELI®280, MLBUR280 and BUR280 Electrocardiographs - FSN 2
Advice regarding a software upgrade. HPRA Ref: V47214
William Cook Europe ApS
Inferior Vena Cava (IVC) Filter
Advice regarding the use of the device. HPRA Ref: V47440
Zimmer Biomet
ROSA One 3.1 Brain application
Advice regarding a software upgrade. HPRA Ref: V47499
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Date Printed: 04/12/2023