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Summary of Field Safety Notices- January 2024
Notice type:
3rd Party Publications
Date:
01/02/2024
Further Information:
3M Company
3M™ Surgical / 3M™ Specialty Clipper Blades
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00F24C
Abbott Ireland Diagnostic Division
Alinity i Anti-HBs Reagent Kit
Advice regarding a device removal, HPRA Reference CRN00F2GX
Abbott Laboratories
Alinity s System
Advice regarding a software upgrade, HPRA Reference CRN00F2DL
Abbott Laboratories
Alinity s System
Advice regarding the use of the device, HPRA Reference CRN00F2R0
Beckman Coulter
DxI 9000 Immunoassay Analyzer
Advice regarding the use of the device, HPRA Reference CRN00F118
Becton, Dickinson and Company
BD Sensi-Disc
Advice regarding the use of the device, HPRA Reference CRN00F0MS
Corcym S.r.l.
Perceval Plus Sutureless Aortic Heart Valve
Advice regarding a device removal, HPRA Reference CRN00F12K
GE Healthcare
Centricity Anesthesia / Critical Care
Advice regarding the use of the device, HPRA Reference CRN00F1XM
GE Healthcare
IC9-RS
Advice regarding a device removal, HPRA Reference CRN00F34R
Gyrus ACMI, Inc. (Olympus Surgical Technologies America)
SOLTIVE Single-use Laser Fibers
Advice regarding a device removal, HPRA Reference CRN00F12S
Hologic Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
Advice regarding the use of the device, HPRA Reference CRN00F2N2
HS Hospital Service SpA
AMICA-GEN
Advice regarding the use of the device, HPRA Reference CRN00F28D
icotec ag
i
icotec Torque Wrench
Advice regarding a device removal, HPRA Reference CRN00F25N
Integra Pain Management
Integra Cranial Access Kit without drugs, bits
Advice regarding a device removal, HPRA Reference CRN00F2D7
Intuitive Surgical, Inc.
da Vinci Xi and da Vinci X Surgical System
Advice regarding the use of the device, HPRA Reference CRN00DY7N
Medtronic Inc.
Everest 30 Inflation Device
Advice regarding a device removal, HPRA Reference CRN00F2CT
Medtronics
PMAC71RSC - Reusable Sensor Cable for PM7100 and PMAC71RIC / Reusable
PMAC71RSC - Reusable Sensor Cable for PM7100 and PMAC71RIC / Reusable Infant Sensor Adapter Cable for PM7100
Advice regarding a device removal, HPRA Reference CRN00F12F
Meyra GmbH
iCHAIR SKY ; 1.620
Advice regarding the use of the device, HPRA Reference CRN00F12G
Mirion Technologies (Capintec), Inc.
Captus 4000e Thyroid Uptake System
Advice regarding the use of the device, HPRA Reference CRN00F12J
Mölnlycke Health Care AB
Emergency Chest Re-opening Pack
Advice regarding a device removal, HPRA Reference CRN00F2WK
Olympus Medical Systems Corporation
Evis Lucera Elite Bronchofibervideoscopes
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00F1FF
Olympus Medical Systems Corporation
Thunderbeat Type – S
Advice regarding a device removal, HPRA Reference CRN00F20H
Ortho-Space Ltd.
InSpace Medium
Advice regarding the use of the device, HPRA Reference CRN00F12D
Philips Medical Systems Nederland BV
Philips Allura Xper, Allura Centron and Azurion
Advice regarding the use of the device, HPRA Reference CRN00F14H
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" FSN 2
"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" FSN 3
Advice regarding the use of the device, HPRA Reference V53624
Siemens Healthcare Diagnostics Inc.
Atellica UAS 800 Analyzer, Atellica 1500 Automated Urinalysis System
Advice regarding the use of the device, HPRA Reference CRN00F2TF
Siemens Healthineers
ARTIS icono/pheno system
Advice regarding changes/updates made to instructions for use, HPRA Reference CRN00F1D4
Smiths Medical
Medfusion™ Syringe Infusion Pump
Advice regarding a device modification, HPRA Reference CRN00F0QZ
Stryker Joint Replacement
HRIS Acetabular Cup Cut Tips
Advice regarding a device removal, HPRA Reference CRN00F1L5
TORNIER SAS
Pyrocardan® TMC Resurfacing Implant
Advice regarding a device removal, HPRA Reference CRN00F1F5
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Date Printed: 30/04/2024