Field Safety Notice: 28 October to 1 November

List of field safety notices (FSNs) from medical device manufacturers from 28 October to 1 November 2019.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

Abbott: Alinity ci Level Sensor, BulkSolution

29 October 2019

IVDs, clinical chemistry

MHRA reference: 2019/010/030/701/025

Abbott: Alinity c Carbon Dioxide Reagent Kit

23 October 2019

IVDs, clinical chemistry

MHRA reference: 2019/010/025/701/007

Abbott: Alinity

29 October 2019

IVDs, clinical chemistry

MHRA reference: 2019/009/018/701/017

Arcomed AG: SP6000, VP7000

04 October 2019

Infusion systems

Model: SP6000 Chroma, VP7000 Chroma

MHRA reference: 2019/010/028/701/011

Bard: Bard® MaxCore® Disposable Core Biopsy Instrument

October 2019

Mammography

MHRA reference: 2019/010/029/701/010

BIOMERIEUX: VIDAS® 3

25 October 2019

IVDs, immunology

MHRA reference: 2019/010/025/487/020

BIOMERIEUX: BACT/ALERT VIRTUO

October 2019

IVDs, bacteriology

MHRA reference: 2019/010/030/701/036

Cardinal Health: 303000 Genius 2 Tympanic Thermometer (discontinued) 303013 Genius 3 Tympanic Thermometer

30 October 2019

Diagnostic measurement and monitoring

Model: 303000, 30301

MHRA reference: 2019/010/031/291/004

Dako: Autostainer Syringe Tray

30 October 2019

IVDs, cytopathology & histopathology

MHRA reference: 2019/010/028/701/016

Edwards Life Sciences: HemoSphere Oximetry Cable

FCA 143

Monitors, patient

Model: HEMOXSC100

MHRA reference: 2019/010/029/291/010

Integra LifeSciences: CUSA Clarity Console

14 October 2019

Therapy tissue ablation

MHRA reference: 2019/010/028/487/015

Karl Storz: C-MAC® Videolaryngoscope

31 October 2019

Airway devices

MHRA reference: 2019/010/021/487/004

LiNA Medical (Stryker): Smoke Evacuation Pencil

October 2019

Surgical, diathermy

MHRA reference: 2019/010/008/228/018

Mediplus

31 October 2019

Urinary catheters and accessories

Model: 5822

MHRA reference: 2019/010/029/291/008

Medtronic: Activa Clinician Programmer Application

October 2019

Implantable neuro stimulators

Model: A610

MHRA reference: 2019/004/002/291/002

NxStage Medical: NxStage System One

10 October 2019

Dialysis, haemodialysis

Model: NX1000-1, NX1000-3, NX1000-3-A

MHRA reference: 2019/010/028/487/019

Philips: HeartStart XL+ Defibrillator/Monitor

October 2019

Defibrillators, non implantable

Model: 861290

MHRA reference: 2019/010/029/291/012

Philips Healthcare: HeartStart XL+ Defibrillator/Monitor

October 2019

Defibrillators, non implantable

Model: 861290

MHRA reference: 2019/010/029/291/007

RaySearch Laboratories AB

25 October 2019

Radiotherapy planning and verification systems

MHRA reference: 2019/010/028/487/039

Roche Diagnostics: Elecsys Troponin T hs

October 2019

IVDs, clinical chemistry

MHRA reference: 2019/010/030/701/035

Siemens: Thromborel S

October 2019

Coagulation

MHRA reference: 2019/010/030/291/019

SSI Diagnostica: ImmuLex H. influenzae polyvalent antiserum

11 October 2019

IVDs, bacteriology

Model: 91467

MHRA reference: 2019/010/029/291/005

Villa Sistemi Medicali: Apollo / DRF/ EZ / EZ DRF; Clinodigit EVO, JunoDRF

23 October 2019

X Ray, fluoroscopy systems

Model: Apollo

MHRA reference: 2019/010/029/487/007

Updates to this page

Published 4 November 2019