Field Safety Notices: 18 to 22 April 2022
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 April 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
BD: BD BodyComm software
19 April 2022
Software as a medical device (SaMD)
MHRA reference: 2022/004/021/291/007
Bio-Rad: Anti-Lua (LU1)
17 March 2022
IVDs, blood transfusion
MHRA reference: 2022/003/022/701/066
Dentsply: Teneo
15 March 2022
Dental, laboratory equipment
Model: 6364157
MHRA reference: 2022/004/006/291/003
GE Healthcare: Carescape Central Station
36150
Monitors, patient
MHRA reference: 2022/004/014/701/02
Getinge: Flow-c. Flow-e
12 April 2022
Anaesthetic machines & monitors
MHRA reference: 2022/004/019/291/005
Siemens Healthineers: AXIOM Sensis XP / Sensis / Sensis Lite
April 2022
Electrophysiology measurement
Model: Lite systems with SW VC12M
MHRA reference: 2022/004/013/601/504
Stryker: SmartToe II
April 2022
Osteosynthesis, bone plates
MHRA reference: 2022/004/019/291/002
Stryker: TRITANIUM BPLATE TRIATHLON
RA2022-2974643
Joint prosthesis, knee
MHRA reference: 2022/004/021/291/001
ThermoFisher Scientific: TaqPath COVID‑19 HT Kit
13 April 2022
IVDs, SARS-CoV-2 PCR test
Model: A50883
MHRA reference: 2022/004/020/701/078