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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