Field Safety Notices: 7 August to 11 August 2023

List of field safety notices (FSNs) from medical device manufacturers from 7th August to 11th 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

Acutronic: fabian HFO, +nCPAP evolution, Therapy evolution

31 July 2023

Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012

MHRA reference: 8915142

BD: Ventralight ST Mesh with Echo PS Positioning System

02 May 2023

Surgical mesh laparoscopic delivery/positioning

MHRA reference: 8914808

CamDiab: CamAPS and mylife CamAPS

04 August 2023

Model: FX

MHRA reference: 8915163

Lowenstein Medical: elisa 300, elisa 500, elisa 600, elisa 800

31 July 2023

Critical Care Ventilator

MHRA reference: 8915358

Randox: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVE

03 August 2023

Multiple clinical chemistry analyte IVD, control

MHRA reference: 8911950

Werfen: ACL TOP Family 50 Series and ACL TOP 970 CL

13 July 2023

Laboratory coagulation analyser

MHRA reference: 8915485

Published 14 August 2023