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
Abbott: Alinity ci Level Sensor, BulkSolution
29 October 2019
IVDs, clinical chemistry
MHRA reference:
Abbott: Alinity c Carbon Dioxide Reagent Kit
23 October 2019
IVDs, clinical chemistry
MHRA reference:
Abbott: Alinity
29 October 2019
IVDs, clinical chemistry
MHRA reference:
Arcomed AG: SP6000, VP7000
04 October 2019
Infusion systems
Model: SP6000 Chroma, VP7000 Chroma
MHRA reference:
Bard: Bard庐 MaxCore庐 Disposable Core Biopsy Instrument
October 2019
Mammography
MHRA reference:
BIOMERIEUX: VIDAS庐 3
25 October 2019
IVDs, immunology
MHRA reference:
BIOMERIEUX: BACT/ALERT VIRTUO
October 2019
IVDs, bacteriology
MHRA reference:
Cardinal Health: 303000 Genius 2 Tympanic 皇冠体育apprmometer (discontinued) 303013 Genius 3 Tympanic 皇冠体育apprmometer
30 October 2019
Diagnostic measurement and monitoring
Model: 303000, 30301
MHRA reference:
Dako: Autostainer Syringe Tray
30 October 2019
IVDs, cytopathology & histopathology
MHRA reference:
Edwards Life Sciences: HemoSphere Oximetry Cable
FCA 143
Monitors, patient
Model: HEMOXSC100
MHRA reference:
Integra LifeSciences: CUSA Clarity Console
14 October 2019
皇冠体育apprapy tissue ablation
MHRA reference:
Karl Storz: C-MAC庐 Videolaryngoscope
31 October 2019
Airway devices
MHRA reference:
LiNA Medical (Stryker): Smoke Evacuation Pencil
October 2019
Surgical, diathermy
MHRA reference:
Mediplus
31 October 2019
Urinary catheters and accessories
Model: 5822
MHRA reference:
Medtronic: Activa Clinician Programmer Application
October 2019
Implantable neuro stimulators
Model: A610
MHRA reference:
NxStage Medical: NxStage System One
10 October 2019
Dialysis, haemodialysis
Model: NX1000-1, NX1000-3, NX1000-3-A
MHRA reference:
Philips: HeartStart XL+ Defibrillator/Monitor
October 2019
Defibrillators, non implantable
Model: 861290
MHRA reference:
Philips Healthcare: HeartStart XL+ Defibrillator/Monitor
October 2019
Defibrillators, non implantable
Model: 861290
MHRA reference:
RaySearch Laboratories AB
25 October 2019
Radiotherapy planning and verification systems
MHRA reference:
Roche Diagnostics: Elecsys Troponin T hs
October 2019
IVDs, clinical chemistry
MHRA reference:
Siemens: Thromborel S
October 2019
Coagulation
MHRA reference:
SSI Diagnostica: ImmuLex H. influenzae polyvalent antiserum
11 October 2019
IVDs, bacteriology
Model: 91467
MHRA reference:
Villa Sistemi Medicali: Apollo / DRF/ EZ / EZ DRF; Clinodigit EVO, JunoDRF
23 October 2019
X Ray, fluoroscopy systems
Model: Apollo
MHRA reference: