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Summary of Field Safety Notices - July 2023
Notice type:
3rd Party Publications
Date:
03/08/2023
Further Information:
Abbott
Proclaim™ XR SCS and Proclaim™ Elite SCS System, Proclaim™ DRG
Neurostimulation System, Infinity™ DBS System
Advice regarding the use of the device, HPRA Ref: CRN00DQGX
Abbott Diabeties Care
FreeStyle LibreLink app for Android, version 2.10.0 FSN 1
FreeStyle LibreLink app for Android, version 2.10.0 FSN 2
Advice regarding the use of the device, HPRA Ref: CRN00DQVJ
Alcon Laboratories, Inc
Phaco tips
Advice regarding the use of the device, HPRA Ref: CRN00DPMJ
Ambu A/S
Ambu® aView 2 Advance
Advice regarding the use of the device, HPRA Ref: CRN00DP90
Atrium Medical Corporation
Advanta V12 Covered Stent System
Advice regarding the use of the device, HPRA Ref: V50671
BD
BD Alaris™ Gateway Workstation
Advice regarding the use of the device, HPRA Ref: CRN00DMRL
Beckman Coulter
Access Folate and Access TSH Reagent Packs
Advice regarding the use of the device, HPRA Ref: CRN00DP28
Cook Endoscopy/Wilson-Cook Medical, Inc.
Fusion Lithotripsy Extraction Basket FS-LXB-2X4, FS-LXB-3X6
Advice regarding a device removal, HPRA Ref: CRN00DP8N
Cook Vandergrift Inc.
Lead Clippers
Advice regarding a device removal, HPRA Ref: CRN00DPZ2
Datascope Corp. / Getinge
Datascope CARDIOSAVE Hybrid IABP, CARDIOSAVE Rescue IABP, Safety Disks, and Pneumatic Interface Module (PIM)
Advice regarding a device modification, HPRA Ref: V54475
Datascope Corp. / Getinge
Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
Advice regarding the use of the device, HPRA Ref: V54387
Datascope Corp. / Getinge
Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
Advice regarding a device modification, HPRA Ref: V54336
Datascope Corp. / Getinge
Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
Advice regarding a device modification, HPRA Ref: V54263
Datascope Corp. / Getinge
Datascope Sensation/Sensation Plus/MEGA/Linear IAB CATHETERS, Packaged Insertion Kits, & Reinforced Introducer Sets
Advice regarding a device removal, HPRA Ref: CRN00DMV2
Draeger Medical Systems, Inc.
Infinity® CentralStation, Infinity® M300/M300+
Advice regarding the use of the device, HPRA Ref: V54451
Dräger
HME TwinStar® Plus and corresponding sets
Advice regarding changes/updates made to instructions for use, HPRA Ref: CRN00DQPK
Edwards Lifesciences LLC
PASCAL Precision Transcatheter Valve Repair System
Advice regarding a device removal, HPRA Ref: CRN00DQQP
Empatica
Embrace2
Advice regarding the use of the device, HPRA Ref: CRN00DQGH
GE Healthcare
TruSignal® SpO2 Sensors
Advice regarding a device removal, HPRA Ref: CRN00DP9D
Getinge
HL 40 Heart-Lung Machine
Advice regarding a device removal, HPRA Ref: CRN00DQ2S
Getinge Disinfection AB
APERLAN PY AGENT A, APERLAN PY AGENT B
Advice regarding the use of the device, HPRA Ref: CRN00DQD3
Hamilton Medical
Hamilton Medical Ventilators HAMILTON-C1/T1/C2/C3 with Neonatal Option
Advice regarding a software upgrade, HPRA Ref: CRN00DPKF
ICU Medical
Plum 360 Infusion System
Advice regarding a software upgrade, HPRA Ref: CRN00DQ5T
Instrumentation Laboratory Co.
ACL TOP Family 50 Series / ACL TOP 970 CL
Advice regarding the use of the device, HPRA Ref: CRN00DQ7Z
Integra LifeSciences
Codman Cranial Access Kit without drugs
Advice regarding a device removal, HPRA Ref: CRN00DQ0W
Inter-med, Inc.
Septodont Parcan N NaOCL 3% Solution
Advice regarding the use of the device, HPRA Ref: CRN00DP8X
Medtronic
O-arm™ O2 Imaging System (O2)
Advice regarding a device modification, HPRA Ref: CRN00DQS8
Mölnlycke Health Care AB
Mölnlycke® Trays with Blink Medical Component: Acute thorax tray & Emergency Chest Re-opening Pack & Thorax trauma tray
Advice regarding a device removal, HPRA Ref: CRN00DPXR
NVT GmbH
ALLEGRA Transcatheter Heart Valve
Advice regarding a device removal, HPRA Ref: CRN00DPQ9
QuidelOrtho
ORTHO VISION and VISION Max Analyzers for BioVue
Advice regarding the use of the device, HPRA Ref: CRN00DP9K
Randox Laboratories Ltd
Liquid Protein Calibrators
Advice regarding a device modification, HPRA Ref: CRN00DQC3
Sartorius
Minisart® HY | SRP Syringe Filters
Advice regarding changes/updates made to instructions for use, HPRA Ref: CRN00DQPS
Shimadzu
RADspeed Pro/RADspeed safire/CH-200/CH-200M
Advice regarding a device modification, HPRA Ref: CRN00DQHP
Siemens Healthineers
Acuson Redwood Ultrasound system
Advice regarding the use of the device, HPRA Ref: CRN00DQ6V
Siemens Healthineers
Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and Atellica CH HDL Cholesterol (HDLC)
Advice regarding the use of the device, HPRA Ref: CRN00DPM3
Smiths Medical
CADD Infusion System Infusion Sets for use with CADD pumps
Advice regarding the use of the device, HPRA Ref: V53605
Megadyne Medical Products, Inc.
MEGADYNE™ Suction Coagulators
Advice regarding a device removal, HPRA Ref: CRN00DMDY
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Date Printed: 29/04/2024