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Summary of Field Safety Notices - March 2020
Notice type:
3rd Party Publications
Date:
02/04/2020
Further Information:
Summary of Field Safety Notices - March 2020
Aesculap
Various Reusable Surgical Equipment
Advice regarding the use of the device. HPRA Ref: V43189
Applied Medical
Epix Latis Grasper
Advice regarding a device removal. HPRA Ref: V43302
Avanos Medical, Inc.
CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit
Advice regarding the use of the device. HPRA Ref: V43344
Axis-Shield Diagnostics Ltd
Alere NT-proBNP Control/Alere NT-proBNP Calibrator
Advice regarding a device removal. HPRA Ref: V43205
Baxter
PrisMax and Prismaflex sets
Advice regarding the use of the device. HPRA Ref: V43342
Biomet Orthopaedics
Orthopaedic Cement Spacer mold
Advice regarding a device removal. HPRA Ref: V43199
Biomet UK Ltd
Biolox Delta Modular Ceramic Heads
Advice regarding a device removal. HPRA Ref: V43188
Boston Scientific Corporation, USA
Sensor Nitinol Guidewires with Hydrophylic Tip
Advice regarding a device removal. HPRA Ref: V43019
GreenLight MoXy Laser Fiber
Advice regarding the use of the device. HPRA Ref: V43215
Covidien LLC, USA
Covidien Force Triverse electrosurgical device
Advice regarding a device removal. HPRA Ref: V42828
Gambro Dialysatoren GMBH
Revaclear 500 Dialyzers
Advice regarding a device removal. HPRA Ref: V42895
GN Hearing A/S
Resound; Beltone
Advice regarding a device removal. HPRA Ref: V41512
Integra LifeSciences
CUSA Clarity Console
Advice regarding changes/updates made to instructions for use. HPRA Ref: V41788
Maquet Critical Care AB
Flow-i, Flow-c and Flow-e anaesthesia machines
Advice regarding the use of the device. HPRA Ref: V43320
Medtronic
Microplas Plasmafiller
Advice regarding a device removal. HPRA Ref: V43104
Medtronic
CareLink Programmer; CareLink Encore Programmer
Advice regarding a software upgrade. HPRA Ref: V37585
Mercado Medic AB
Real 9000 Plus Wheelchair
Advice regarding the use of the device. HPRA Ref: V43286
MERIT MEDICAL
DFINE Vertebral Hydraulic Assemblies
Advice regarding a device removal. HPRA Ref: V42929
MESI, development of medical devices, Ltd
Automated ankle brachial pressure index measuring (MESI ABPI MD)
Advice regarding the use of the device. HPRA Ref: V40844
Natus
RemLogic Software 4.0
Advice regarding a device removal. HPRA Ref: V43204
Philips
HeartStart MRx Monitor / Defibrillator
Advice regarding the use of the device. HPRA Ref: V43101
Philips V60 Ventilators
Advice regarding a device modification. HPRA Ref: V43219
Radiometer Medical
ABL800 analyzers
Advice regarding a software upgrade. HPRA Ref: V43054
RAL Diagnostics
Giemsa Solution for SP Automated Systems
Advice regarding a device removal. HPRA Ref: V42508
Schiller
FRED Easy / FRED Easy Skity Defibrillators
Advice regarding a device modification. HPRA Ref: V43209
Shenzen Mindray Bio-Medical Electronics Co., Ltd.
VS-900, N12, N15, N17, N19 patient monitors
Advice regarding a device modification. HPRA Ref: V42760
Siemens Healthcare Diagnostics
Atellica CH 930 Reaction Cuvette Segment
Advice regarding the use of the device. HPRA Ref: V42624
Smith & Nephew
Footprint Ulta PK Suture Anchor
Advice regarding a device removal. HPRA Ref: V43338
SYSMEX Europe GmbH
Automated Urine Analyzer
Advice regarding a software upgrade. HPRA Ref: V43085
Teleflex
Arrow Multi-Lumen Catheter
Advice regarding a device removal. HPRA Ref: V43148
Langston Dual Lumen Catheter
Advice regarding a device removal. HPRA Ref: V43252
The Binding Site
NK019.OPT-Optlite C1 Inactivator Kit
Advice regarding the use of the device. HPRA Ref: V43258
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Date Printed: 27/07/2024