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

View a

View . FSNs before this date are on the

Aeonmed: VG70

29 March 2021

Lung ventilators

MHRA reference:

Atos Medical: Provox Life Night HME

30 March 2021

Breathing system components

Model: 8262

MHRA reference:

Beaver Visitec International: BVI CustomEyes Kits and Malosa Kits

26 March 2021

Phacoemulsification / vitrectomy systems

MHRA reference:

Biopsybell: Various Devices

January 2021

Vascular cannula and catheters

MHRA reference:

CareDx: SCORE 6

26 March 2021

IVDs, clinical chemistry

MHRA reference:

Eurofins Forensic Services: Eurofins

02 April 2021

VDs, SARS-CoV-2 PCR test

MHRA reference:

Getinge: Cardiosave Intra-Aortic Balloon Pumps

23 March 2021

Cardiac assist pumps

Model: 0998-XX-0800-XX

MHRA reference:

Medical Enterprises: Synergo

21 March 2021

Therapy tissue ablation

Model: LI932B

MHRA reference:

OptiMed: Cemento Mini Set for Cemento-MP

06 April 2021

Bone Cement and tools

MHRA reference:

Philips Medical Systems: Philips Xper Flex Cardio Physiomonitoring System

April 2021

Monitors, patient

MHRA reference:

Randox Laboratories: Calibration Serum Level 3

29 March 2021

IVDs, clinical chemistry

MHRA reference:

Updates to this page

Published 19 April 2021