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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 Analyzerr
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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