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Summary of Field Safety Notice - April 2023
Notice type:
3rd Party Publications
Date:
04/05/2023
Further Information:
Atrium Medical Corporation
Express Mini 500 Dry Seal Chest Drain
Advice regarding changes/updates made to instructions for use. HPRA Ref: V54715
Atrium Medical Corporation
Pneumostat Chest Drain Valve
Advice regarding changes/updates made to instructions for use. HPRA Ref: V54715
Beckman Coulter Ireland Inc.,
Bicarbonate (HCO3-) IVD, kit, enzyme spectrophotom
Advice regarding a device removal. HPRA Ref: V54678
Carl Zeiss Meditec AG (CZM AG)
AT TORBI 709MP
Advice regarding a device removal. HPRA Ref: V54614
Cook Medical
Advance Micro™ 14 Ultra Low-Profile PTA Balloon Catheter,
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter
Advice regarding a device removal. HPRA Ref: V53841
DePuy
Cemvac Revision Nozzle 6.5mm & 8.5mm
Advice regarding a device removal. HPRA Ref: V54933
DePuy Mitek
Bioknotless Anchor
Advice regarding the use of the device. HPRA Ref: V54891
Exmoor Plastics Ltd
Exmoor Plastics Nasal Splints
Advice regarding a device removal. HPRA Ref: V54724
Exocad GmbH
Exoplan
Advice regarding the use of the device. HPRA Ref: V55026
GE Healthcare
Centricity PACS-IW, (PACS-IW) Centricity PACS-IW with Universal Viewer (UV-IW) and Centricity Universal Viewer with PACS-IW foundation (UV-IW)
Advice regarding a software upgrade. HPRA Ref: V54957
Johnson & Johnson International
PDS® Plus Antibacterial (polydioxanone) Suture
Advice regarding a device removal. HPRA Ref: V54521
Medtronic Navigation, Inc.
StealthStation™ S7/i7 Cranial Software v3.1.1, 3.1.2, and 3.1.3
Advice regarding a software upgrade. HPRA Ref: V48047
Olympus
4K CAMERA HEAD CH-S400-XZ-EB
Advice regarding changes/updates made to instructions for use. HPRA Ref: V54722
Olympus Corporation
Vizishot2 SINGLE USE ASPIRATION NEEDLE
Advice regarding a device removal. HPRA Ref: V54552
Olympus Medical Systems Corporation
SINGLE USE DISTAL COVER MAJ-2315
Advice regarding a device removal. HPRA Ref: V54797
Ossur
Icelock Ratchets
Advice regarding a device removal. HPRA Ref: V54973
Philips
Trilogy Evo, Trilogy Evo O2, Trilogy EV300
Advice regarding the use of the device. HPRA Ref: V54744
Philips
EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor
Advice regarding a software upgrade. HPRA Ref: V54863
RAL Diagnostics
Buffer solution for automated systmes
Advice regarding a device removal. HPRA Ref: V54972
Roche
BenchMark ULTRA & DISCOVERY ULTRA
Advice regarding the use of the device. HPRA Ref: V50173
Siemens Healthineers
Atellica CH Toxicology Calibrators (TOX CAL)
Advice regarding the use of the device. HPRA Ref: V54642
Stryker
TIBIAL BASEPLATE STD RM/LL
Advice regarding a device removal. HPRA Ref: V54522
Stryker GmbH
Transport Strut Hoffmann LRF
Advice regarding a device removal. HPRA Ref: V54047
Thermo Fischer Scientific
Thermo Scientific™ Oxoid™ MacConkey Agar without Salt
Advice regarding a device removal. HPRA Ref: V54820
Thermo Fischer Scientific
EliA GliadinDP IgG Well
Advice regarding changes/updates made to instructions for use. HPRA Ref: V54979
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Date Printed: 26/04/2024