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
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View . FSNs before this date are on the
BD: BD BodyComm software
19 April 2022
Software as a medical device (SaMD)
MHRA reference:
Bio-Rad: Anti-Lua (LU1)
17 March 2022
IVDs, blood transfusion
MHRA reference:
Dentsply: Teneo
15 March 2022
Dental, laboratory equipment
Model: 6364157
MHRA reference:
GE Healthcare: Carescape Central Station
36150
Monitors, patient
MHRA reference:
Getinge: Flow-c. Flow-e
12 April 2022
Anaesthetic machines & monitors
MHRA reference:
Siemens Healthineers: AXIOM Sensis XP / Sensis / Sensis Lite
April 2022
Electrophysiology measurement
Model: Lite systems with SW VC12M
MHRA reference:
Stryker: SmartToe II
April 2022
Osteosynthesis, bone plates
MHRA reference:
Stryker: TRITANIUM BPLATE TRIATHLON
RA2022-2974643
Joint prosthesis, knee
MHRA reference:
皇冠体育apprmoFisher Scientific: TaqPath COVID鈥�19 HT Kit
13 April 2022
IVDs, SARS-CoV-2 PCR test
Model: A50883
MHRA reference: