Field Safety Notices (FSNs) from 14 to 18 August 2023
List of Field Safety Notices (FSNs) from 14 to 18 August 2023.
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 . FSNs before this date are on the
Abbott: Gallant, Neutrino, Entrant
August 2023
Defibrillator, Implantable, biventricular
Model: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, CDHFA300Q
MHRA reference: 2022/005/017/611/003
Baxter: EVO IQ Large Volumetric Pump
07 August 2023
Infusion pump, general-purpose
Model: ELVP001UKI (applicable in UK) ELVP001GRC
MHRA reference: 2023/008/004/601/008
Berlin Heart: EXCOR Cannulae
August 2023
Circulatory assist unit ventricular
MHRA reference: / 2023/008/014/601/022
Fujifilm: Synapse PACS
Ref 20220930
Picture archiving and communication system, radiology
MHRA reference: 2023/003/029/601/035
Siemens Healthineers: ADVIA Chemistry Iron_2 (IRON_2) Reagents
August 2023
Iron IVD, kit, spectrophotometry
MHRA reference: / 2023/008/011/601/023
Werfen: HemosIL AcuStar ADAMTS13
27 June 2023
MHRA reference: