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Summary of Field Safety Notices- November 2022
Notice type:
3rd Party Publications
Date:
05/12/2022
Further Information:
3M
3MTM Steri-DrapeTM Surgical Drapes
Advice regarding a device removal. HPRA Ref: V53040
Agfa Healthcare NV
Enterprise Imaging XERO Viewer
Advice regarding the use of the device. HPRA Ref: V53458
Armstrong Medical Ltd
Double swivel elbow
Advice regarding a device removal. HPRA Ref: V53420
Arrow International LLC
Arrow® AutoCAT®2 Intra-Aortic Balloon Pump;Arrow® AC3 Optimus® Intra-Aortic Balloon Pump
Advice regarding the use of the device. HPRA Ref: V53228
BD (Becton, Dickinson and Company)
Catheter Repair Kits (Various)
Advice regarding a device removal. HPRA Ref: V53302
CooperSurgical
NEO-fit™ Neonatal Endotracheal Tube Grip
Advice regarding a device removal. HPRA Ref: V53053
Cordis Corporation
Angiographic Catheter Extensions
Advice regarding a device removal. HPRA Ref: V53191
DiaMed GmbH - Cressier
IH-500
Advice regarding a software upgrade. HPRA Ref: V52749
Drägerwerk AG & Co.KGaA
Dräger Polaris Multimedia: single display mounting system, ceiling bearing D60 MO, part numbers G28994 and G92759
Advice regarding a device modification. HPRA Ref: V53237
Gambro Renal Products Inc.
REVACLEAR 300 Dialyzer, REVACLEAR 400 Dialyzer
Advice regarding the use of the device. HPRA Ref: V53430
GE Healthcare
Centricity PACS-IW with Universal Viewer 5.x
Advice regarding a software upgrade. HPRA Ref: V53353
Getinge
ED-FLOW AER and ED-FLOW SD AER
Advice regarding a software upgrade. HPRA Ref: V53159
Intersurgical Ltd
Neonatal, Nasal Cannu with Curv Pron and Tube, 2.1m
Advice regarding the use of the device. HPRA Ref: V53391
L&R Medical UK Ltd
Activia Thigh Length Open toe hosiery
Advice regarding a device removal. HPRA Ref: V53264
Life Technologies Corporation, a part of Thermo Fisher Scientific
TaqPath COVID-19 HT Kit
Advice regarding a software upgrade. HPRA Ref: V52773
Maquet Cardiopulmonary GmbH
PLS Set
Advice regarding the use of the device. HPRA Ref: V53214
Medtronic Inc.
Vanta LT Clinician Programmer Application
Advice regarding the use of the device. HPRA Ref: V53461
Medtronic MiniMed
Guardian Application
Advice regarding a software upgrade. HPRA Ref: V53383
Molecular Diagnostics at Abbott
Alinity m Resp-4-Plex AMP Kit
Advice regarding a device removal. HPRA Ref: V53418
NISSHA Medical Technologies
CLARAVUE ECG Prewired Electrodes
Advice regarding the use of the device. HPRA Ref: V50551
Northgate Technologies, Inc.
Autolith Touch BSC
Advice regarding the use of the device. HPRA Ref: V52261
Nucletron B.V.
Oncentra brachy
Advice regarding a software upgrade. HPRA Ref: V53405
Olympus Medical Systems Corporation
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
Advice regarding changes/updates made to instructions for use. HPRA Ref: V53301
Philips
HeartStart Intrepid Monitor/Defibrillator
Advice regarding a device removal. HPRA Ref: V53359
Philips
Fetal Measurements
Advice regarding the use of the device. HPRA Ref: V53421
Philips Medical Systems
M5071A Adult and M5072A Infant/child pads cartridges for use with HS1/OnSite/Home AEDs
Advice regarding a device modification. HPRA Ref: V53342
Roche
Ventana PD-L1 (SP142) IHC Assay
Advice regarding the review of patient results/patient recall/ sample retesting is required. HPRA Ref: V53303
Teleflex Medical Europe
RUSCH Ureteral Catheters; RUSCH Superglide Integal Plus; RUSCH Valve Uretheral Stents; RUSCH Valve DD Uretheral Stents
Advice regarding a device removal. HPRA Ref: V48351
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Date Printed: 26/04/2024