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Summary of Field Safety Notice – September 2016
Notice type:
3rd Party Publications
Date:
03/10/2016
Further Information:
bbott Medical Optics
TECNIS Various Models & SENSAR Acrylic Monofocal
Advice regarding a device removal. HPRA Ref: V29115
Alere San Diego Inc.
Alere INRatio®/INRatio®2 PT/INR Monitoring System
Alere INRatio®/INRatio®2 PT/INR Monitoring System FSN 2
Advice regarding a device removal. HPRA Ref: V28428
Animas Corporation
Animas® Vibe® Insulin Pump
Advice regarding the use of the device. HPRA Ref: V29147
B. Braun
Spinocath®
Advice regarding a device removal. HPRA Ref: V29258
Baxter Healthcare Corporation
VASCU-GUARD Peripheral Vascular Patch
Advice regarding the use of the device. HPRA Ref: V28322
BES Corporate
Varilite Cushion Valve Seating Integrity
Advice regarding a device modification. HPRA Ref: V29171
Biocartis NV
IdyllaTM KRAS Mutation Test
Advice regarding the use of the device. HPRA Ref: V29142
Biomet 3i (Zimmer Biomet)
Low Profile products
Advice regarding a device removal. HPRA Ref: V29255
CareFusion
Avea Ventilator
Advice regarding a device modification. HPRA Ref: V27981
Ecolab Limited
Klerpack BD Syringe Multi-Pack
Advice regarding a device removal. HPRA Ref: V29189
Edwards Lifesciences LLC
FEM FLEX II Arterial Cannulae
Advice regarding a device removal. HPRA Ref: V20556
Flowonix
Prometra® Programmable Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29279
Focus Diagnostics Inc. DBA DiaSorin Molecular LLC
Simplexa™ Flu A/B & RSV Direct Integrated Cycler
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29121
GE Healthcare
Ohio Infant Warmer Systems
Advice regarding the use of the device. HPRA Ref: V29247
GE Healthcare
MAGiC T2 FLAIR
Advice regarding the use of the device. HPRA Ref: V29228
ICU Medical
Advice regarding a device removal
Tego Connector. HPRA Ref: V29215
LeMaitre Vascular
1.5 mm Hydro LeMaitre® Valvulotome
Advice regarding a device removal. HPRA Ref: V28776
LivaNova (Sorin Group Italia S.R.L)
REPLY, ESPRIT, KORA and FACIL pacemakers
Advice regarding the use of the device. HPRA Ref: V29375
Mindray
Dryline II Water Trap
Advice regarding a device removal. HPRA Ref: V29232
Pennine Healthcare
Ryles Tubes
Advice regarding the use of the device. HPRA Ref: V29122
Philips
IntelliVue MX40
Advice regarding a software upgrade. HPRA Ref: V29260
Philips Medical Systems
Brilliance 64 and Ingenuity CT/Core/Core128
Advice regarding a software upgrade. HPRA Ref: V29197
Quotient
ALBAcyte® A2 Cells REAGENT RED CELLS
Advice regarding a device removal. HPRA Ref: V29132
R&D Systems Inc.
Quantikine® IVD® Human sTfR Immunoassay
Advice regarding a device removal. HPRA Ref: V29286
Radiometer
ABL90 Flex / ABL90 Plus
Advice regarding the use of the device. HPRA Ref: V29183
Randox Laboratories Ltd
Magnesium – MG3880 – Rx Imola
Advice regarding the use of the device. HPRA Ref: V29327
Randox Laboratories Ltd.
Evidence Investigator Analyser EV3602, EV3602R, software version 1.7.2
Advice regarding a software upgrade. HPRA Ref: V29324
Roche
Combur-Test / ChoiceLine 10 test method sheets
Advice regarding the use of the device. HPRA Ref: V29210
Roche
Cobas C111 Analyzer
Advice regarding the use of the device. HPRA Ref: V29259
Roche
Multiple Rack Trays
Advice regarding the use of the device. HPRA Ref: V29249
Sciex
Analyst MD Software
Advice regarding a software upgrade. HPRA Ref: V27232
Siemens Healthcare
Artis systems with 19" Live Display
Advice regarding a device modification. HPRA Ref: V28435
Siemens Healthcare
Dimension & Dimension Vista IRON Flex reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V29206
Siemens Healthcare
ADVIA Centaur PSA
Advice regarding the use of the device. HPRA Ref: V28695
Siemens Healthcare
RAPIDPoint 400/405 Systems
Advice regarding the use of the device. HPRA Ref: V29160
Stryker Orthopaedics
Scorpio Patella Assembly Instrument
Advice regarding a device removal. HPRA Ref: V28845
Stryker Orthopaedics
Trident Universal Impactor / Positioner
Advice regarding a device removal. HPRA Ref: V29091
Welch Allyn Ltd
MS3 Connex Spot Classic Mobile Stand & Power Supply
Advice regarding a device modification. HPRA Ref: V29152
Zimmer Biomet
Air Dermatome II
Advice regarding a device removal. HPRA Ref: V28394
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Date Printed: 01/10/2023