Field Safety Notices: 9 to 13 October 2023

List of Field Safety Notices from 9 to 13 October 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

Breas: Vivo 1, Vivo 2, Vivo 3

06 October 2023

Portable ventilator, electric

MHRA reference: 27446020

Change Healthcare: Radiology Solutions

10 October 2023

Radiology PACS Software

Model: 14.1

MHRA reference: 27459485    

Intersurgical: Clear-Therm 3 HMEF with Luer Port

07 March 2023

Heat/moisture exchanger/microbial medical gas filt

MHRA reference: 5099922

Medicare Colgate: Sterifeed Colostrum Collector

26 September 2023

Model: 1ml

MHRA reference: 27448649      

Medtronic: Mo.Ma Ultra Cerebral Protection Device

October 2023

Model: MOM0130069X6, MOM0130068X5

MHRA reference: 27459008    

One Lambda: C1Q Screen

07 September 2023

HLA class I & II antibody screening IVD, kit

MHRA reference: 27446107    

Shimadzu: RADspeed Pro / RADspeed safire/CH-200/CH-200M

10 April 2023

MHRA reference: 27446608    

Siemens Healthineers: Atellica CH 930 Analyzer

September 2023

MHRA reference: 27448627    

Unomedical: Varisoft

11 October 2023

Electric infusion pump administration set

Model: 1002827, 1002828, 1002830, 1001681, 1002832

MHRA reference: 27454302

Published 16 October 2023