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

Updates to this page

Published 10 December 2018