Field safety notices - 03 to 07 December 2018
Summary List of field safety notices (FSNs) from medical device manufacturers from 03 to 07 December 2018
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
Acutronic: fabian Therapy evolution / fabian +nCPAP evolution
22 November 2018
Lung ventilators
MHRA reference: 2018/011/029/701/023
Carl Zeiss
30 November 2018
Therapy, lasers
Model: VisuMax
MHRA reference: 2018/011/030/601/005
Ecolab: ISI Instrument & Camera Arm Drape, Disposable Kit
ECL-FSCA-122
Surgical drapes, gowns, masks MHRA reference: 2018/012/004/291/014
Elekta: MOSAIQ
December 2018
Radiotherapy
MHRA reference: 2018/011/030/701/016
GE: Centricity Universal Viewer
GEHC Ref# 85446 Picture Archiving and Communication System (PACS) MHRA reference: 2018/012/005/291/007
Halyard Health: ENTRAL Side Load Clamp for Tubes ≤ 14Fr
03 December 2018
Feeding systems and tubes Model: 800-SM
MHRA reference: 2018/012/004/487/010
Leica: Aperio CS2
30 November 2018
IVDs, cytopathology & histopathology MHRA reference: 2018/012/004/701/001
LivaNova SAS: VNS Therapy® Generators
6 December 2018
Implants, active, stimulators, neuro
Model: Model 1000 SenTiva MHRA reference: 2018/012/003/291/008
Roche Diagnostics: BILT3, Lactate, LACT2, IgM-2
November 2018
IVDs, clinical chemistry
MHRA reference: 2018/012/003/291/017
Stryker: EDS LIGHT SUSPENSION CENTRAL AXIS
November 2018
Lamps & lights
MHRA reference: 2018/011/027/487/009
Thermo Fisher: Oxoid Brilliance™ ESBL/Brilliance™ CRE Bi-Plate
05 December 2018
IVDs, bacteriology
MHRA reference: 2018/012/005/601/004
Vygon: Dualstop
3 December 2018
Injection devices Model: 009888001 and 009888002 MHRA reference: 2018/012/003/601/001