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
Updates to this page
Last updated 20 December 2018 + show all updates
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Added entry for Allergan Breast Implants and Tissue Expanders.
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First published.