Field Safety Notice: 02 to 06 September 2019
List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 September 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
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
Olympus: MAJ-209 SINGLE USE SUCTION VALVE
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