Field Safety Notice: 21 to 26 September 2020

List of field safety notices (FSNs) from medical device manufacturers from 21 to 26 September 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.

Brainlab: ExacTrac Dynamic

8 September 2020

Radiotherapy planning and verification systems

Model: 20910-01

MHRA reference: 2020/009/024/487/008

Drive Devilbiss: Universal bed rails

30 June 2020

Beds and accessories

MHRA reference: 2020/006/030/601/005

GE Healthcare Medical Systems: Various models affected – see FSN

GEHC Ref# 60968

Magnetic resonance, equipment & accessories

MHRA reference: 2020/009/018/291/005

Leica: BOND Enzyme Pretreatment kit

21 September 2020

IVDs, cytopathology & histopathology

MHRA reference: 2020/009/024/601/005

Maquet - Getinge: Blood Monitoring Unit BMU 40

18 September 2020

Diagnostic measurement and monitoring

Model: 70104.0852

MHRA reference: 2020/009/021/487/001

Olympus: Intestinal Videoscope Olympus

21 September 2020

Endoscopes, flexible

Model: POWERSPIRAL (PSF-1)

MHRA reference: 2020/009/010/291/002

Philips: Switched/Switchless Internal Paddles

4 September 2020

Implants, active, defibrillator leads

Model: Switched M4741A, M4742A, M4743A, M4744A

Switchless M1741A, M1742A, M1743A, M1744A (Instructions for use)

MHRA reference: 2020/009/024/487/003

Siemens (Shenzhen): ARTIS one

September 2020

X Ray, fluoroscopy systems

Model: 10848600

MHRA reference: 2020/009/021/601/006

Siemens: UROSKOP OMNIA and UROSKOP OMNIA MAX

XP024/20/S

X Ray, fluoroscopy systems

Model: 10094910 and 10762473

MHRA reference: 2020/009/021/601/005

Siemens: Artis icono and Artis pheno

September 2020

X Ray, fluoroscopy systems

Model: see enclosure

MHRA reference: 2020/009/021/601/004

Smiths Medical: Medfusion

17 August 2020

Infusion systems

Model: Medfusion 3500 and Medfusion 4000

MHRA reference: 2020/008/024/291/001

Steripack: Syringe 10 ml with 0,9% sodium chloride (An update to FSN 20 -24 July 2020)

23 September 2020

Vascular cannula/catheter accessories

MHRA reference: 2020/009/003/291/005

Tornier: Inspyre™ Implant

23 September 2020

Joint prosthesis, shoulder

Model: Interpositional Shoulder Implant

MHRA reference: 2020/009/023/487/008

W.L. Gore & Associates: GORE® TAG® Conformable Thoracic Stent Graft

21 September 2020

Implants, non-active, endoprostheses for aortic aneurysms

MHRA reference: 2020/009/011/487/005

Updates to this page

Published 28 September 2020