Field Safety Notices: 09 to 13 May 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 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.
BioMérieux: VITEK 2 System
28 April 2022
IVDs, bacteriology
MHRA reference: 2022/005/012/611/002
DiaSys Diagnostic Systems: HDL-c direct FS
27 April 2022
IVDs, clinical chemistry
MHRA reference: 2022/005/012/593/002
Molnlycke Health Care: Procedure Trays
12 April 2022
Surgical devices, non-powered
MHRA reference: 2022/005/012/291/001
Oxehealth: Vital Signs
05 April 2022
Software as a medical device
Model: Vital Signs 1
MHRA reference: 2022/003/024/291/001
Smiths Medical: Medfusion 3500 and 4000 Syringe Infusion Pumps
27 April 2022
Electrically powered infusion pump
Model: See FSN -Table 1 - Affected products, models, versions
MHRA reference: 2022/003/030/291/001