Field Safety Notice - 10 - 14 December 2018

List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 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

07 December 2018

Lung ventilators

Model: abian HFO/fabian +nCPAP evolution/ fabian Therapy evolution

MHRA reference: 2018/012/010/291/006

Allergan: Allergan Breast Implants and Tissue Expanders

FSCA-18-001

Implants, breast

MHRA reference: 2018/012/019/291/006

Diffuplast srl: ExactaMix

22 November 2018

Feeding systems and tubes

MHRA reference: 2018/012/006/487/017

Drager: Jaundice Meter

November 2018

Diagnostic measurement and monitoring

Model: JM-105

MHRA reference:2018/004/017/291/014

###Elekta: MOSAI

Q and Sequencer

December 2018

Radiotherapy

MHRA reference: 2018/012/012/487/002

Ethicon

PROXIMATE® Hemorrhoidal Circular Stapler

Staples and staple guns

MHRA reference: 2018/012/006/701/024

GE: CARESCAPE B850

FMI 36135

Monitors, patient

MHRA reference: 2018/012/010/291/003

GE: Discovery NM 530c, Ventri

FMI 40880

Nuclear medicine

MHRA reference: 2018/012/012/291/001

Hitachi (Roche): cobas 8100 system

07 December 2018

IVDs, clinical chemistry

Model: 07123841001 / 07123850001

MHRA reference: 2018/012/012/291/004

Hologic: I-View Contrast Enhanced Digital Mammography

FA-00056

Mammography

MHRA reference: 2018/012/010/601/008

Ion Beam Applications: Proteus 235

10 December 2018

Radiotherapy

MHRA reference: 2018/012/010/487/018

Peters Surgical: Trocar ENDOSPHERE

07 June 2018

Surgical instruments, minimal access

MHRA reference: 2018/012/010/291/001

Roche: Accu-Chek® Insight

December 2018

Infusion systems

Model: 00700006889

MHRA reference: 2018/011/028/701/019

Schuchmann: Malte, Malte-Outdoor, MArcy; 7502000,7502100,

7503000, 7504000, 7503100, 7602000,7603000, 7602100, 7603100 /

18 April 2018

Walking aids, walking frames

MHRA reference: 2018/005/022/478/002

Siemens: Atellica IM Analyzer: Anti-Thyroglobulin (aTG) ; ADVIA Centaur/XP/XPT and ADVIA Centaur CP anti-Tg (aTG

December 2018

IVDs, clinical chemistry

MHRA reference: 2018/012/012/601/001

Terumo: Trima Accel Automated Blood Collection System

December 2018

Apheresis

MHRA reference: 2018/012/010/291/004

Vertex: Vertex Castavaria

05 December 2018

Dental materials

MHRA reference:2018/012/010/291/002

Published 18 December 2018
Last updated 20 December 2018 + show all updates
  1. Added entry for Allergan Breast Implants and Tissue Expanders.
  2. First published.