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Summary of Field Safety Notices - October 2021
Notice type:
3rd Party Publications
Date:
01/11/2021
Further Information:
Summary of Field Safety Notices - October 2021
Abbott
"A SUBSET OF ASSURITY™ AND ENDURITY™ PACEMAKERS MODELS PM1152, PM1160, PM1172, PM1240, PM1272, PM2152, PM2160, PM2172, PM2240, PM2260, PM2272"
Advice regarding the use of the device. HPRA Ref: V47588
HeartMate Touch Communication System
Advice regarding the use of the device. HPRA Ref: V47783
Beckman Coulter Eurocenter S.A.
Stem-Kit Reagents 50 Tests - FSN
Advice regarding the use of the device. HPRA Ref: V47597
Stem-Kit Reagents 50 Tests - Response Form
Advice regarding the use of the device. HPRA Ref: V47597
BioFire Diagnostics
BioFire BCID2 Panel
Advice regarding the use of the device. HPRA Ref: V47697
BioMérieux SA
MYLA V4.7 SOFTWARE ; MYLA V4.8 SOFTWARE - FSN1
Advice regarding a software upgrade. HPRA Ref: V47455
MYLA V4.7 SOFTWARE ; MYLA V4.8 SOFTWARE - FSN2
Advice regarding a software upgrade. HPRA Ref: V47455
Boston Scientific Corporation
Hurricane RX Biliary Balloon Dilatation Catheter
Advice regarding a device removal. HPRA Ref: V47661
Cook Incorporated
Transseptal Needle & Transseptal Needle with catheter
Advice regarding a device removal. HPRA Ref: V47593
Copan Italia SPA
Eswab
Advice regarding changes/updates made to instructions for use. HPRA Ref: V47612
Cordis Cashel
S.M.A.R.T. Flex Vascular Stent System
Advice regarding a device removal. HPRA Ref: V47528
FUJIFILM Irvine Scientific
Vitrification Freeze Kit
Advice regarding the use of the device. HPRA Ref: V47658
Integra Lifesciences
Accudrain / Hermetic / LimiTorr / MoniTorr
Advice regarding the use of the device. HPRA Ref: V47619
Medtronic
MiniMed 600 series insulin pump retainer ring - FSN1
Advice regarding a device removal. HPRA Ref: V42217
MiniMed 600 series insulin pump retainer ring - FSN2
Advice regarding a device removal. HPRA Ref: V42217
Percept PC BrainSense
Advice regarding the use of the device. HPRA Ref: V47660
CareLink SmartSync Device Manager
Advice regarding a software upgrade. HPRA Ref: V47685
Medtronic Incorporated
Endurant II/Iis Stent Graft System
Advice regarding a device removal. HPRA Ref: V47662
Mentor
Mentor® Smooth Round Saline DV Breast Implants
Advice regarding a device removal. HPRA Ref: V47765
Nucletron B.V.
Oncentra® Brachy
Advice regarding a software upgrade. HPRA Ref: V47650
Oticon Medical
Neuro Zti EVO, Neuro Zti CLA
Advice regarding a device removal. HPRA Ref: V47593
Philips
Ingenia 1.5T, Ingenia 1.5T Evolution, Ingenia 1.5T S, Ingenia 1.5T CX, SmartPath to dStream for 1.5T, Ingenia 3.0T, Ingenia Ambition S,
Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Ingenia 3.0T CX, SmartPath to dStream for XR and 3.0T
Advice regarding a device modification. HPRA Ref: V47419
Philips Azurion R2.1.x System
Advice regarding a software upgrade. HPRA Ref: V47696
Philips Ultrasound, Inc.
Philips EPIQ & Affiniti Ultrasound Systems - FSN2
Advice regarding a software upgrade. HPRA Ref: V47415
Siemens Healthcare GmbH
Artis zee /Q /Q.zen systems with software version VD12
Advice regarding a software upgrade. HPRA Ref: V47729
Siemens Healthineers
ARTIS pheno, ARTIS icono biplane and ARTIS icono floor
Advice regarding a software upgrade. HPRA Ref: V47636
Smith & Nephew Inc.
EVOS 3.5mm * 75mm LCK SCR S-T/EVOS 3.5mm * 70mm
Advice regarding a device removal. HPRA Ref: V47809
Smiths Medical
Level 1® Fast Flow Fluid Warming System and Level 1® NORMOFLO® Irrigation System
Advice regarding the use of the device. HPRA Ref: V47220
TiSport
Wheelchair
Advice regarding a device modification. HPRA Ref: V47541
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Date Printed: 26/04/2024