Summary of Field Safety Notices - September 2024

Notice type: 3rd Party Publications

Date: 07/10/2024

  

Further Information:
Summary of Field Safety Notices- September 2024

Datascope Corp.
Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue
Advice regarding a software upgrade. HPRA Ref:CRN00DP8K


BioRad/DiaMed GmbH
Coombs Anti-IgG, ID-DiaCell I-II-III, LISS/Coombs
Advice regarding the use of the device. HPRA Ref:CRN00F62C


Respironics, Inc.
All BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro devices
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00F7HC


Randox Laboratories Ltd.
Randox HbA1c Calibrator Set
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00FDCP


Merit Medical Systems, Inc. USA
Randox HbA1c Calibrator Set
Advice regarding a device removal. HPRA Ref:CRN00FMX6


GS Elektromedizinische Geräte G. Stemple GmbH
Battery corpuls cpr (LiPo) REF 09120
Advice regarding a device modification. HPRA Ref:CRN00FN6X

  
Siemens Medical Solutions USA, Inc. Ultrasound
ACUSON Redwood
Advice regarding a software upgrade. HPRA Ref:CRN00FN72


GE Healthcare GmbH
Viewpoint
Advice regarding a software upgrade. HPRA Ref:CRN00FNNQ


Philips Medical Systems Nederland BV
Allura Xper, Azurion, Integris, MultiDiagnost Eleva
Advice regarding a device modification. HPRA Ref:CRN00FNNW

  
CROMA-PHARMA GmbH
NuVisc Pro
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00FNSF


Boston Scientific Corporation
AVVIGO+ Multi-Modality Guidance System
Advice regarding the use of the device. HPRA Ref:CRN00FNSY


Datex-Ohmeda, Inc.
Giraffe Warmer, Panda iRes Warmer
Advice regarding the use of the device. HPRA Ref:CRN00FNTQ


Leica Biosystems Nussloch GmbH
Leica Biosystems Cryostats
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00FNW3


lmmunotech S.A.S. - A Beckman Coulter Company
Access TSH (3rd IS) 2x200 DET Reagent Packs
Advice regarding a device removal. HPRA Ref:CRN00FNZ8


Smiths Medical. ASD Inc. (currently "ICU Medical Inc.")
CADD Medication Cassette Reservoir
Advice regarding a device removal. HPRA Ref:CRN00FP3F


ArcRoyal uc, an Owens & Minor Company
Halyard IR1080 and IR1087 CPT
Advice regarding a device removal. HPRA Ref:CRN00FP5G


Caesarea Medical Electronics Limited
BodyGuard MultiPurpose Infusion Pump System
Advice regarding the use of the device. HPRA Ref:CRN00FPDL


B.Braun Melsungen AG
Spaceplus Perfusor® (with TOM functionality)
Advice regarding a software upgrade. HPRA Ref:CRN00FPG9


GE Healthcare
Centricity PACS System
Advice regarding the use of the device. HPRA Ref:CRN00FPHY


Olympus Medical Systems Corporation
Bronchovideoscope (BFH1100), Bronchovideoscope (BF-1TH1100), EVIS EXERA III Gastrointestinal Videoscope (GIF-H190N), EVIS EXERA III Small Intestinal Videoscope (SIF-H190), Gastrointestinal Videoscope (GIF-1100)
Advice regarding a device removal. HPRA Ref:CRN00FPXH


Medtronic Inc.
Wireless Recharger Kits, Models RS6230 and RS7230
Advice regarding a device removal. HPRA Ref:CRN00FQ7Q


Olympus KeyMed
OFP 2 Flushing Pump
Advice regarding the use of the device. HPRA Ref:CRN00FQ81


Covidien llc
Chameleon™ Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter
Advice regarding a device removal. HPRA Ref:CRN00FQC8


BK Medical Aps
bk3500, bk3000, bk5000 & bkActiv 2300 Ultrasound Devices with battery option
Advice regarding the use of the device. HPRA Ref:CRN00FQDG


Blink Medical
Yankauer Suction Tube
Advice regarding a device removal. HPRA Ref:CRN00FQGV


Philips Respironics, Inc.
Trilogy Evo, Trilogy Evo O2, Trilogy EV300
Advice regarding the use of the device. HPRA Ref:CRN00FQHR


Smiths Medical
CADD-Solis AC Adapter Model 21-0270-25
Advice regarding the use of the device. HPRA Ref:CRN00FQK7


Smiths Medical
CADD-Solis Ambulatory Infusion Pump Rechargeable Battery Pack
Advice regarding the use of the device. HPRA Ref:CRN00FQKR


Jenx Ltd
Ly-on
Advice regarding the use of the device. HPRA Ref:CRN00FQPP


GE Healthcare
Centricity Universal Viewer Zero Footprint client
Advice regarding a software upgrade. HPRA Ref:CRN00FQPS


Datascope Corporation
MEGA Intra-aortic balloon catheter
Advice regarding a device removal. HPRA Ref:CRN00FQPX


Medacta International
GMK Sphere Tibial Insert Flex
Advice regarding a device removal. HPRA Ref:CRN00FQTJ


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