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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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