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Summary of Field Safety Notices - September 2022
Notice type:
3rd Party Publications
Date:
05/10/2022
Further Information:
Abbott Hematology
Alinity hq Analyzer, Alinity hs Slide Maker Stainer Module
Advice regarding a software upgrade. HPRA Ref: V52594
Abbott Vascular
MitraClipTM G4 Clip Delivery System,
MitraClipTM NTR/XTR Clip Delivery System, TriClipTM NT/XT Clip Delivery System, and TriClipTM G4 Delivery System
Advice regarding the use of the device. HPRA Ref: V52553
Actim Oy
Actim 1ngeni
Advice regarding a software upgrade. HPRA Ref: V52547
Aesculap AG
SUSI EVES TONSIL SNARE 285mm
Advice regarding a device removal. HPRA Ref: V52751
Boston Scientific
FarawaveTM Pulsed Field Ablation Catheter and FarastarTM Pulsed Field Ablation Generator
Advice regarding changes/updates made to instructions for use. HPRA Ref: V52579
DiaMed GmbH
IH-QC8
Advice regarding a device removal. HPRA Ref: V52575
GE Healthcare
Aisys CS2, Avance CS2, and Avance CS2 Pro Anesthesia Systems
Advice regarding a device modification. HPRA Ref: V52516
Instrumentation Laboratory Co.
ACL Top 300 CTS, ACL Top 350 CTS, ACL Top 500 CTS, ACL Top 550 CTS, and ACL TOP 970 CL
Advice regarding the use of the device. HPRA Ref: V50744
J&J Surgical Vision
Veritas Advanced Infusion Packs
Advice regarding a device removal. HPRA Ref: V52544
Le Maitre Vascular Inc.
Syntel Silicone Over the Wire Embolectomy Catheter
Advice regarding a device removal. HPRA Ref: V52448
Medtronic
Endo Stitch V-Loc 180 Absorbable Reload, Endo Stitch V-Loc PBT Non-Absorbable Reload
Advice regarding a device removal. HPRA Ref: V52692
Medtronic
MiniMed 640G Insulin Pump, MiniMed 670G Insulin Pump. FSN 1
MiniMed 640G Insulin Pump, MiniMed 670G Insulin Pump. FSN 2
Advice regarding the use of the device. HPRA Ref: V52741
Nipro Corporation
Surdial X
Advice regarding the use of the device. HPRA Ref: V52699
Philips Medical Systems
MR Patient Care Portal 5000. FSN 1
MR Patient Care Portal 5000. FSN 2
Advice regarding a software upgrade. HPRA Ref: V52317
Roche
cobas 5800 Instrument model:08707464001
Advice regarding the use of the device. HPRA Ref: V52610
Roche
cobas e 801 and e 402
Advice regarding a software upgrade. HPRA Ref: V51999
Siemens
Lithium, Lithium_2 Assay
Advice regarding a device removal. HPRA Ref: V52598
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE D-Dimer Controls
Advice regarding changes/updates made to instructions for use. HPRA Ref: V51333
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Date Printed: 26/04/2024