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 the 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

Abbott: Gallant, Neutrino, Entrant

August 2023

Defibrillator, Implantable, biventricular

Model: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, CDHFA300Q

MHRA reference: 13385832 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: 8911964 2023/008/004/601/008

Berlin Heart: EXCOR Cannulae

August 2023

Circulatory assist unit ventricular

MHRA reference: 12468950 / 2023/008/014/601/022

Fujifilm: Synapse PACS

Ref 20220930

Picture archiving and communication system, radiology

MHRA reference: 5139849 2023/003/029/601/035

Siemens Healthineers: ADVIA Chemistry Iron_2 (IRON_2) Reagents

August 2023

Iron IVD, kit, spectrophotometry

MHRA reference: 12038929 / 2023/008/011/601/023

Werfen: HemosIL AcuStar ADAMTS13

27 June 2023

MHRA reference: 13313949

Updates to this page

Published 24 August 2023