Field Safety Notice: 02 to 06 September 2019

List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 September 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

Biomet: Vanguard XP Tibial Tray

29 August 2019

Joint prosthesis, knee

Model: 15mmØ Collapsible/Extendible Tubing - present in Armstrong Medical Catheter Mounts, Face Mask Kits and some Breathing Circuits

MHRA reference: 2019/009/002/291/001

Corin: MetaFix Collared

29 August 2019

Joint prosthesis, hip

Model: 579.2103

MHRA reference: 2019/008/003/601/003

Corin: TriFit TS

29 August 2019

Joint prosthesis, hip

Model: 694.0001

MHRA reference: 2019/008/009/601/003

Drive Devilbiss: Knight Scooter

02 September 2019

Scooters, powered

MHRA reference: 2019/009/003/601/002

EIZO: RadiForce GX560, RadiForce RX360

27 August 2019

X ray, general

Model: GX560, RX360

MHRA reference: 2019/008/028/291/007

Elekta: Monaco RTP System

August 2019

Radiotherapy planning and verification systems

MHRA reference: 2019/009/002/701/027

Fresenius Medical Care: AV-SET B-R & AV-Set SRB-R

28 August 2019

Dialysis, blood lines

Model: F00001124 & F00000257

MHRA reference: 2019/008/029/487/026


August 2019

Endoscopes, flexible

MHRA reference: 2019/008/028/291/006

Pajunk: SPROTTE Lumbal

30 August 2019

Injection devices

Model: 321151-30C, 331151-31B

MHRA reference: 2019/009/002/291/003

Quality Electrodynamics: TxRx Knee Coil/Quality Electrodynamics

29 August 2019

Magnetic resonance, equipment & accessories

MHRA reference: 2019/008/030/701/021

Randox Laboratories: Rheumatoid Factor Standard, Liquid Protein Calibrators

30 August 2019

IVDs, clinical chemistry

Model: RF2301, IT2691

MHRA reference: 2019/009/002/601/001

Siemens: Atellica UAS 800 Analyzer

August 2019

IVDs, clinical chemistry

MHRA reference: 2019/008/029/601/010

Published 9 September 2019