Field Safety Notices - 4 to 8 May 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 4 to 8 May 2020

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

Elekta: Accelerator system, linear

April 2020

Radiotherapy

Model: Elekta Unity

MHRA reference: 2020/005/001/291/001

Endologix: Br Ovation Abdominal Stent Graft System Platformand

06 May 2020

Implants, non active, endoprostheses for aortic aneurysm

Model: TV-AB2080-I, TV-AB2380-I, TV-AB2680-I, TV-AB2980-I, TV-AB3480-I

MHRA reference: 2020/005/006/291/003

Eurovema Mobility: Euroflex work chairs with the Forma chassis

6.6.2-2019-47648

Wheelchairs, manual

Model: 80xxxxxx, 241-xx, 242-xx, 291-xx, 292-xx, 841-xx, 891-xx

MHRA reference: 2020/005/004/601/001

Fluoron: F-Octane (syringe), F-Decalin (syringe)

11 April 2019

Injection devices

MHRA reference: 2019/010/031/291/005

Ivoclar Vivadent: IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5

24 April 2020

Dental materials

MHRA reference: 2020/004/006/291/002

Radiometer: ABL800 with FlexQ

FAN 915-412

IVDs, extra laboratory testing

Model: 393-800, 393-801

MHRA reference: 2020/005/006/291/002

Siemens Healthcare: Cios Alpha & Cios Spin

April 2020

X Ray, fluoroscopy systems

Model: See FSN

MHRA reference: 2020/004/027/601/001

Siemens Healthcare AX035/19/S: Artis zee / Artis Q / Q.zen

April 2020

X Ray, fluoroscopy systems

MHRA reference: 2020/004/030/601/003

Updates to this page

Published 11 May 2020