Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
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
« Back
Date Printed: 14/11/2024