Field Safety Notice: 4 to 8 March 2019
List of field safety notices (FSNs) from medical device manufacturers from 4 to 8 March 2019
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
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
Radiotherapy
MHRA reference: 2019/003/004/291/010
Medtronic: Pulmonary Vein Catheter GOLD (PVAC GOLD
March 2019
Therapy tissue ablation
990078
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