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