Field Safety Notice: 4 to 8 March 2019

List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 March 2019


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

Abbott: CELL-DYN Emerald

21 February 2019

IVDs, haematology

MHRA reference: 2019/002/025/701/016

Abbott: Alinity hq Analyzer

28 February 2019

IVDs, haematology

MHRA reference: 2019/003/004/701/017

Abbott: Alinity i,c Processing Modules, Alinity s system

1 March 2019

IVDs, clinical chemistry

MHRA reference: 2019/003/004/701/016

Bard: Vaginal Mesh for Prolapse

07 March 2019

Implants, non-active, implantable

MHRA reference: 2019/002/025/291/005

Biocomposites: Genex Putty 5cc

27 February 2019

Implant materials, bone substitutes

Model: 920-005

MHRA reference: 2019/003/004/291/030

Elekta: Elekta Unity

December 2018


MHRA reference: 2019/003/004/291/010

Medtronic: Pulmonary Vein Catheter GOLD (PVAC GOLD

March 2019

Therapy tissue ablation


MHRA reference: 2019/003/006/487/003

Medtronic: Charging System, RestoreSensor Charging System

February 2019

Implants, active, stimulators, neuro

37651, 37754 and 97754 (containing the model 37751 recharger)

MHRA reference: 2016/010/018/131/004

Vision: Vision+

01 March 2019

Clinical patient record system

MHRA reference: 2019/001/028/487/007

Stratec: BioStratec GEMINI und Stratec GEMINI Combo

01 February 2019

IVDs, clinical chemistry

9162800000 and 9162250000

MHRA reference: 2019/002/027/291/001

Smith & Nephew: EVOS 2.7mm Inferior Distal Clavicle Plate13H Right

28 February 2019

Osteosynthesis, bone plates

MHRA reference: 2019/003/007/701/007

Published 11 March 2019