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Summary of Field Safety Notice - February 2023
Notice type:
3rd Party Publications
Date:
02/03/2023
Further Information:
B.Braun
Infusomat Space Transfusion Line
Advice regarding the use of the device, HPRA Ref: V54024
Baxter Healthcare SA
EVO IQ Large Volumetric Pump
Advice regarding a device modification, HPRA Ref: V45642
Brainlab AG
ExacTrac Dynamic
Advice regarding a software upgrade, HPRA Ref: V54106
Care Dx AB
Olerup SSP HLA-A low
Advice regarding a device removal, HPRA Ref: V54161
Carnamedica Sp. z o.o.
Belzer UW® ; Belzer MPS®; StoreProtect® FSN 1
Belzer UW® ; Belzer MPS®; StoreProtect® FSN 2
Advice regarding a device removal, HPRA Ref: V54019
Elekta
Monaco RTP System
Advice regarding a software upgrade, HPRA Ref: V54250
Hamilton Medical
HAMILTON-C6 Ventilator
Advice regarding a software upgrade, HPRA Ref: V54217
Intuitive Surgical Inc.
SureForm 45 / SureForm 45 Curved-Tip / SureForm 60
Advice regarding the use of the device, HPRA Ref: V54049
Maquet Cardiopulmonary GmbH
PLS Set; HLS Set Advanced 5.0; HLS Set Advanced 7.0
Advice regarding the use of the device, HPRA Ref: V53214
Nidek Co. LTD
EyeCee ONE preloaded&EyeCee ONE Crystal preloaded
Advice regarding a device removal, HPRA Ref: V53782
Philips Medical Systems Nederland BV
SmartPerfusion OWB; 2D Perfusion OWB
Advice regarding a device removal, HPRA Ref: V54219
Physio-Control, Inc. , Stryker
LIFEPAK® CR2 DEFIBRILLATOR
Advice regarding the use of the device, HPRA Ref: V54044
Remote Diagnostic Technologies Ltd.
Tempus Pro Patient Monitor
Advice regarding a device modification, HPRA Ref: V54214
Roche
cobas pro sample supply unit
cobas 80000 Core Unit.
Cobas 513 analyzer.
Advice regarding a software upgrade. HPRA Ref: V45304
Roche
cobas pure e 402 analytical unit
Advice regarding a software upgrade, HPRA Ref: V51999
Siemens
Lithium, Lithium_2 Assay
Advice regarding changes/updates made to instructions for use, HPRA Ref: V52598
Siemens
ACLELITE/ ACL ELITE PRO/ ACLEiite Ref/ ACLEiitePro
Advice regarding a device modification, HPRA Ref: V54185
Siemens Healthcare Diagnostics Inc
ADVIA Centaur Herpes-2 IgG (HSV2)
Advice regarding the use of the device, HPRA Ref: V45744
Siemens Healthineers
ARTIS pheno, ARTIS icono biplane, ARTIS icono floor
Advice regarding a device modification, HPRA Ref: V53643
Siemens Healthineers
Luminos Agile (VC10), Luminos Agile Max (VE10, VF10, VF11), Luminos dRF (VD10), Luminos Drf Max (VE10, VF10, VF11), Luminos Lotus Max
Advice regarding a device modification, HPRA Ref: V54183
SINOVO Health Solutions GmbH
mylife App
Advice regarding a software upgrade, HPRA Ref: V54174
St. Jude Medical
CardioMEMS Patient and Hospital Electronics System FSN HCPs
CardioMEMS Patient and Hospital Electronics System FSN HCPs Appendix
CardioMEMS Patient and Hospital Electronics System FSN HCPs Patients
Advice regarding the use of the device, HPRA Ref: V54056
St. Jude Medical
CardioMEMS PA Sensor and Delivery System FSN
CardioMEMS PA Sensor and Delivery System Appendix A
CardioMEMS PA Sensor and Delivery System Appendix B
Advice regarding the use of the device, HPRA Ref: V54057
St. Jude Medical
Trifecta Valve and Trifecta Valve with Glide Technology
Advice regarding the use of the device, HPRA Ref: V54285
Weinmann Medical Technology
MEDUMAT Standard²
Advice regarding a software upgrade, HPRA Ref: V53962
Caesarea Medical Electronics Ltd
BD BodyGuard™ MicroSets FSN 1
BD BodyGuard™ MicroSets FSN 2
Advice regarding the use of the device, HPRA Ref: V54051
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Date Printed: 26/04/2024