Field Safety Notices - 05 April to 09 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 05 April to 09 April 2021

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

Aeonmed: VG70

29 March 2021

Lung ventilators

MHRA reference: 2021/003/031/291/002

Atos Medical: Provox Life Night HME

30 March 2021

Breathing system components

Model: 8262

MHRA reference: 2021/003/025/601/002

Beaver Visitec International: BVI CustomEyes Kits and Malosa Kits

26 March 2021

Phacoemulsification / vitrectomy systems

MHRA reference: 2021/004/006/291/001

Biopsybell: Various Devices

January 2021

Vascular cannula and catheters

MHRA reference: 2021/003/030/487/017

CareDx: SCORE 6

26 March 2021

IVDs, clinical chemistry

MHRA reference: 2021/003/024/701/061

Eurofins Forensic Services: Eurofins

02 April 2021

VDs, SARS-CoV-2 PCR test

MHRA reference: 2021/003/031/291/001

Getinge: Cardiosave Intra-Aortic Balloon Pumps

23 March 2021

Cardiac assist pumps

Model: 0998-XX-0800-XX

MHRA reference: 2021/004/006/291/017

Medical Enterprises: Synergo

21 March 2021

Therapy tissue ablation

Model: LI932B

MHRA reference: 2021/003/023/601/005

OptiMed: Cemento Mini Set for Cemento-MP

06 April 2021

Bone Cement and tools

MHRA reference: 2021/004/006/701/058

Philips Medical Systems: Philips Xper Flex Cardio Physiomonitoring System

April 2021

Monitors, patient

MHRA reference: 2021/004/006/291/009

Randox Laboratories: Calibration Serum Level 3

29 March 2021

IVDs, clinical chemistry

MHRA reference: 2021/004/001/601/017

Updates to this page

Published 19 April 2021