Field Safety Notices: 25 to 29 July 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 July 2022.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
B. Braun: ENNOVATE IMPLANTS SY001TS
11 July 2022
Osteosynthesis, Bone Screws
MHRA reference: 2022/007/011/601/500
bioMérieux: VIDAS FT4
22 July 2022
IVDs, Viral Microbiology
MHRA reference: 2022/007/021/596/001
bioMérieux: VITEK 2 System
26 July 2022
IVDs, Bacteriology
MHRA reference: 2022/007/021/596/002
GCE: Combi Valve
22 July 2022
Regulators for gas cylinders
Model: 0718112, 0718139, 0718140, 0718113, 0718138
MHRA reference: 2022/007/028/291/006
GE Healthcare: SIGNA Premier
Ref 60986
Magnetic Resonance, Equipment & Accessories
MHRA reference: 2022/007/020/701/203
GE Healthcare: Centricity Universal Viewer
Ref 85465
Picture Archiving And Communication System (PACS)
MHRA reference: 2022/007/028/596/001
Getinge: 701069073, 701069076, 701069083 HLS Set Advanced 5.0, HLS Set Advanced 7.0
July 2022
Infusion & Transfusion, Heart Lung Circuits
MHRA reference: 2022/007/026/596/004
INTCO: Quickie Q50R
11 July 2022
Wheelchairs, Powered
MHRA reference: 2022/007/026/596/001
Medtronic: HeartWare Ventricular Assist System
July 2022
Implantable Ventricular Assist Devices
Model: MCS1705PU, 1104
MHRA reference: 2022/005/012/611/003
Meridian Medical: Valon
08 July 2022
Ophthalmic, Laser
MHRA reference: 2022/007/020/596/011
Siemens: Atellica IM 1300 and IM 1600 Analyzers
April 2022
IVDs, Clinical Chemistry
Model: (SMN 11066001) & (SMN 11066000)
MHRA reference: 2022/004/021/601/501
ThermoFisher Scientific: vRapID NF PLUS System 20/K Remel
21 July 2022
IVDs, Bacteriology
MHRA reference: 2022/007/021/601/009
Ventinova Medical: Evone
31 May 2021
Lung Ventilators
Model: REF: 6000
MHRA reference: 2021/006/002/487/022