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Summary of Field Safety Notices - August 2024
Notice type:
3rd Party Publications
Date:
03/09/2024
Further Information:
Summary of Field Safety Notices- August 2024
Beckman Coulter
Access HBc Ab Reagent
Advice regarding a device removal. HPRA Ref: CRN00FFMD
Welch Allyn, Inc.
Braun Thermoscan Pro 6000 - FSN 1
Advice regarding the use of the device. HPRA Ref:CRN00FHNV_CleaningGuide
Welch Allyn, Inc.
Braun Thermoscan Pro 6000 - FSN 2
Advice regarding the use of the device. HPRA Ref:CRN00FHNV_FSN_Updated
Bruker Daltonics GmbH & Co. KG
UMIC Colistin
Advice regarding a device removal. HPRA Ref:CRN00FJYW
Becton Dickinson and Company
"BD Phoenix™ M50 Automated Microbiology System Instrument, BD Phoenix™ 100 Automated Microbiology System Instrument,
Advice regarding the use of the device. HPRA Ref:CRN00FKJP
Siemens Healthcare Diagnostics Inc 1
"Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) - FSN 1
Advice regarding a device removal. HPRA Ref:CRN00FKWM_FSN(1)
Siemens Healthcare Diagnostics Inc 2
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)"- FSN 2
Advice regarding a device removal. HPRA Ref:CRN00FKWM_FSN(2)
Boston Scientific Corporation, USA
WallFlex & Agile Esophageal Stent Systems
Advice regarding a device removal. HPRA Ref:CRN00FKY4
Abiomed Inc.
Impella 5.5; Impella CP® (with SmartAssist®)
Advice regarding the use of the device. HPRA Ref:CRN00FL3Y
Stryker Instruments
iBur ™ Distal Bend Cutting Accessories
Advice regarding a device removal. HPRA Ref:CRN00FL90
Medartis AG, Switzerland
1.2 K-Draht, Lanzette, 150mm
Advice regarding a device removal. HPRA Ref:CRN00FLHW
Boston Scientific Limited
Vercise Genus™ Implantable Pulse Generator System
Advice regarding the use of the device. HPRA Ref:CRN00FLL3
Cook Biotech Inc. USA
Biodesign Fistula Plug
Advice regarding a device removal. HPRA Ref: CRN00FLN8
GE Hualun Medical Systems Co. Ltd
Proteus XR/a
Advice regarding changes/updates made to instructions for use. HPRA Ref:CRN00FLP0
Philips Medical Systems Nederland BV
Philips Allura Xper
Advice regarding the use of the device. HPRA Ref:CRN00FLQD
Össur hf
Miami J® Select cervical collar
Advice regarding a device removal. HPRA Ref:CRN00FLZK
GE HealthCare
Centricity Universal Viewer Zero Footprint client
Advice regarding a software upgrade. HPRA Ref:CRN00FM18
Becton Dickinson and Company
BD FACSDuet™ Sample Preparation Systems
Advice regarding a software upgrade. HPRA Ref:CRN00FM24
Mölnlycke Health Care AB
Extremity drape
Advice regarding a device removal. HPRA Ref:CRN00FM81
GE healthcare
Anaesthia systems
Advice regarding the use of the device. HPRA Ref:CRN00FMCD
Philips Medical Systems Nederland BV
Philips Azurion System
Advice regarding the use of the device. HPRA Ref:CRN00FMCP
Maquet Cardiopulmonary GmbH
Quadrox Complete Pack, Membrane Perfusion Pack, Complete Neonatal Pack with HM, Miniaturised Neonatal Pack
Advice regarding a device removal. HPRA Ref:CRN00FMF5
Diagnostic Grifols S.A.
ERYTRA EFLEXIS
Advice regarding the use of the device. HPRA Ref:CRN00FMJY
Alcon Laboratories
Dailies Total1 & TOTAL30 soft contact lens
Advice regarding a device removal. HPRA Ref:CRN00FMKL
Siemens Healthcare Diagnostics Inc
Atellica CH Microalbumin_2
Advice regarding the use of the device. HPRA Ref:CRN00FMLF
ICU Medical(Smith Medical)
BLUSelect®, BLUgriggs® and BLUperc® Trach products
Advice regarding a device removal. HPRA Ref:CRN00FMLR
S.I.D.EM. S.p.A
TEE Care System
Advice regarding a device modification. HPRA Ref:CRN00FMPL
Olympus Medical Systems Corporation
High Flow Insufflation Unit (UHI-4)
Advice regarding a software upgrade. HPRA Ref:CRN00FMRD
Medtronic Inc.
DLP™ Single Stage Venous Cannulae
Advice regarding a device removal. HPRA Ref:CRN00FMX0
Fisher & Paykel Healthcare
Airvo 3 FSN 1
Advice regarding a software upgrade. HPRA Ref:CRN00FMXV_FSN_distributor
Fisher & Paykel Healthcare
Airvo 3 FSN 2
Advice regarding a software upgrade. HPRA Ref:CRN00FMXV_FSN_HCP
Siemens Healthcare Diagnostics Inc.
Atellica IM Anti-Thyroid Peroxidase (aTPO) Assay
Advice regarding a device removal. HPRA Ref:CRN00FN0W
The Surgical Company International BV
Fluido Trauma/ Fluido Standard set sterile
Advice regarding the use of the device. HPRA Ref:CRN00FN17
Maquet Cardiopulmonary GmbH
VKMO 70000 #SQUADROX-i HMO 70000+VHK7100
Advice regarding a device removal. HPRA Ref:CRN00FN3Q
Siemens Medical Solutions USA, Inc. Ultrasound
ACUSON Juniper and ACUSON Maple
Advice regarding a software upgrade. HPRA Ref:CRN00FN5P
Abbott Ireland Diagnostics Division Sligo
Alinity i HBsAg Controls, ARCHITECT HBsAg Controls
Advice regarding a device removal. HPRA Ref:CRN00FN6G
Change Healthcare Canada Company
Change Healthcare Cardiology Hemo/Hemodynamic
Advice regarding a software upgrade. HPRA Ref:CRN00FNF4
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Date Printed: 16/10/2024