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Summary of Field Safety Notices - October 2023
Notice type:
Advisory
Date:
03/11/2023
Further Information:
Abbott Laboratories
Alinity s System
Advice regarding the use of the device, HPRA Ref No: CRN00DXD8
Becton Dickinson
BD Alaris™ Pump Sets, Gravity, and Extension infusion sets
Advice regarding the use of the device, HPRA Ref No: CRN00DW36
Maquet Cardiopulmonary GmbH
CARDIOHELP Emergency Drive
Advice regarding a device modification, HPRA Ref No: CRN00DW2T
Maquet Cardiopulmonary GmbH
CARDIOHELP-i
Advice regarding changes/updates made to instructions for use, HPRA Ref No: CRN00DSMK
St. Jude Medical
CardioMEMS Patient Electronic System - FSN 1
CardioMEMS Patient Electronic System - FSN 2
Advice regarding the use of the device, HPRA Ref No: CRN00DVYH
Change Healthcare Canada Company
Change Healthcare Radiology Solutions
Advice regarding a software upgrade, HPRA Ref No: CRN00DX35
Carestream Health Inc
DRX-REVOLUTION MOBILE X-RAY SYSTEM
Advice regarding a device modification, HPRA Ref No: CRN00DVWX
Siemens Healthineers
epoc® NXS Host
Advice regarding the use of the device, , HPRA Ref No: CRN00DWPP
Olympus Medical Systems Corporation
EVIS EXERA BRONCHOVIDEOSCOPE, OES BRONCHOFIBERSCOPE, BRONCHOVIDEOSCOPE, EVIS EXERAII BRONCHOVIDEOSCOPE, EVIS EXERA III BRONCHOVIDEOSCOPE, EVIS LUCERA BRONCHO VIDEOSCOPE, EVIS LUCERA AFI BRONCHO VIDEOSCOPE, EVIS LUCERA ELITE BRONCHOVIDEOSCOPE
Advice regarding the use of the device, HPRA Ref No: CRN00DXG1
Olympus Medical Systems Corporation
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Advice regarding the use of the device, HPRA Ref No: CRN00DXGP
Olympus Medical Systems Corporation
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
Advice regarding the use of the device, HPRA Ref No: CRN00DWYC
Exocad GmbH
Exoplan
Advice regarding a software, HPRA Ref No: CRN00DWZP
Exocad GmbH
Exoplan
Advice regarding a software upgrade, HPRA Ref No: CRN00DXMK
Arthrex INC
FiberTape® Cerclage Disposable Tensioner
Advice regarding a device removal, HPRA Ref No: CRN00DWK6
Philips Goldway (Shenzhen) Industrial Inc.
HeartStart Intrepid Monitor/Defibrillator
Advice regarding changes/updates made to instructions for use, HPRA Ref No: CRN00DWX8
Cetro Medical AB
Hegenberger Retractor
Advice regarding the use of the device, HPRA Ref No: CRN00DVPR
Abbott Diagnostics Scarborough
ID NOW™ Instrument
Advice regarding a software upgrade, HPRA Ref No: CRN00DX05
Integra Pain Management
Integra Cranial Access Kit without drugs, bits
Advice regarding a device removal, HPRA Ref No: CRN00DX0R
Smiths Medical
Jelco® IV Catheter 4013
Advice regarding a device removal, HPRA Ref No: CRN00DT74
Randox Laboratories Ltd
Randox Total Bilirubin
Advice regarding a device modification, HPRA Ref No: CRN00DW7X
Mölnlycke Health Care AB
S.R.R Surgical component within Mölnlycke® Procedure Trays
Advice regarding a device removal, HPRA Ref No: CRN00DWFV
Medtronic Navigation, Inc.
SOFTWARE APP 9735762 STEALTH S8 APPLICATION
Advice regarding the use of the device, HPRA Ref No: CRN00DVMQ
Medicare Colgate
SteriFeed Colostrum Collector
Advice regarding the use of the device, HPRA Ref No: CRN00DWVZ
Edwards Lifesciences LLC
TruWave Disposable Pressure Transducer ,FloTrac Sensors, Acumen IQ Sensors
Advice regarding the use of the device, HPRA Ref No: CRN00DW4F
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Venue Go
Advice regarding the use of the device, HPRA Ref No: CRN00DVYF
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Date Printed: 30/04/2024