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Summary of Field Safety Notices - September 2023
Notice type:
3rd Party Publications
Date:
04/10/2023
Further Information:
Summary of Field Safety Notices - September 2023
Beckman Coulter
Access hsTnI Reagent
Advice regarding the use of the device, HPRA ref:CRN00DVJH
Beckman Coulter
DxI 9000 Access Immunoassay Analyzer
r
Advice regarding the use of the device, HPRA ref:CRN00DT9F
Becton Dickinson
BD BACTEC™ Plus Aerobic/F Culture Vials
Advice regarding the use of the device, HPRA ref:CRN00DTKZ
Cardiac Pacemaker Inc
EMBLEM™ S-ICD and EMBLEM™ MRI S-ICD
Advice regarding a software upgrade, HPRA ref:CRN00DTT5
Carestream Health Inc
DRX-REVOLUTION MOBILE X-RAY SYSTEM
Advice regarding a device modification, HPRA ref:CRN00DVQ6
Carl Zeiss Suzhou Co., Ltd.
OPMI LUMERA 300
Advice regarding the use of the device, HPRA ref:CRN00DTT4
Datascope Corp.
Datascope Intra-Aortic Balloon Catheter (IABs)
Advice regarding the use of the device, HPRA ref:CRN00DMV2
Eitan Medical Ltd
Sapphire™ Multi-Therapy
Advice regarding the use of the device, HPRA ref:CRN00DTWL
GE Healthcare
Centricity Enterprise Archive; Enterprise Archive
Advice regarding a software upgrade, HPRA ref:CRN00DTLL
GE Healthcare
Centricity PACS; Centricity Universal Viewer
Advice regarding a software upgrade, HPRA ref:CRN00DVQ8
GE Healthcare
Prucka 3 Amplifiers used with CardioLab/ComboLab systems
Advice regarding the use of the device, HPRA ref:CRN00DT65
GE Healthcare Finland Oy
Frame F2-01
Advice regarding a software upgrade, HPRA ref:CRN00DTVL
Getinge
Atrium Ocean, Oasis, and Express Chest Drains
Advice regarding changes/updates made to instructions for use, HPRA ref:CRN00DVL2
HeartSine Technologies LLC
HeartSine Samaritan® PAD
Advice regarding a device removal, HPRA ref:V55184
joimax GmbH
Versicon Spine Pump JISP3000
Advice regarding a device modification, HPRA ref: CRN00DSZC
Masimo Corporation
TC-I Reusable Tip Clip Sensor
Advice regarding a device removal, HPRA ref:CRN00DTYK
Medtronic Navigation, Inc.
SOFTWARE APP 9735762 STEALTH S8 APPLICATION
Advice regarding the use of the device, HPRA ref:CRN00DVMQ
Olympus Medical Systems Corporation
Disposale EMR Kit and Distal attachments
Advice regarding a device removal, HPRA ref:CRN00DRJ6
Olympus Medical Systems Corporation
Olympus Flexible Endoscopes with channels
Advice regarding the use of the device, HPRA ref:CRN00DTYH
PEROUSE MEDICAL
DOLPHIN inflation device
Advice regarding a device removal, HPRA ref:CRN00DT81
Philips Medical Systems
Xper Flex Cardio Devices
Advice regarding the use of the device, HPRA ref:CRN00DT6P
QuidelOrtho on behalf of Quotient
ORTHO™ Sera Anti-Lea
Advice regarding a device removal, HPRA ref:CRN00DQ5Y
Quotient/ Alba Bioscience Ltd
ALBAcyte® A1 Cells
Advice regarding a device removal, HPRA ref:CRN00DV3X
Randox Laboratories Ltd
RX Daytona Plus, RX Imola, RX Modena, RX Monaco
Advice regarding a device modification, HPRA ref:CRN00DRR3
SENTINEL CH. S.p.A.
IRON (Ref. 6K95-41), IRON (Ref. 6K95-30), Alinity c Iron Reagent Kit (Ref. 08P3920)
.
Advice regarding a device removal, HPRA ref:CRN00DVMP
Siemens Healthcare GmbH
Cios Alpha VA30, Cios Spin VA30, Cios Flow VA30
Advice regarding a software upgrade, HPRA ref:CRN00DTPV
Siemens Healthcare GmbH
Over-ear headphones
Advice regarding a device modification, HPRA ref:CRN00DVF0
Siemens Healthineers
RAPIDPoint 500 Blood Gas System and RAPIDPoint 500e Blood Gas System
Advice regarding the use of the device, HPRA ref:CRN00DV6N
STRYKER INSTRUMENTS
Malis® Bipolar Forceps
Advice regarding a device removal, HPRA ref:CRN00DTNC
Technopath Manufacturing Ltd
Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus, Multichem P
Advice regarding the use of the device, HPRA ref:CRN00DSL5
Zimmer Surgical, Inc.
Zimmer® Dermatome Blades
Advice regarding a device removal, HPRA ref:CRN00DTYD
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Date Printed: 02/05/2024