Field Safety Notices - 16 to 20 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 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

Antec International: Rely+On Perasafe

01 September 2018

Disinfectants for medical devices

Model: All pack sizes: 16.2g; 81g; 162g, and; 810g

MHRA reference: 2020/002/024/601/006

Becton Dickinson: BD Alaris™ System PC Unit Model 8000 and 8015

04 February 2020

Infusion systems

Model: 8000; 8015

MHRA reference: 2020/002/013/291/001

Chromsystems Instruments: Multilevel Plasma Calibrator Set Neuroleptics 1

12 March 2020

IVDs, clinical chemistry

Model: 92028/XT; 0211/XT; 0212/XT

MHRA reference: 2020/003/017/291/003

Drive Devilbiss: Drive DeVilbiss Healthcare

16 March 2020

Oxygen concentrators

MHRA reference: 2020/003/018/601/003

Eppendorf: Centrifuges5910 R

28 November 2019

Centrifuges

MHRA reference: 2020/003/019/291/002

Euroimmun: Anti-Zika Virus ELISA IgG

04 March 2020

IVDs, viral microbiology

MHRA reference: 2020/003/005/291/010

GCE: COMBILITE

10 February 2020

Regulators for gas cylinders

MHRA reference: 2020/003/019/291/006

Philips: Philips Azurion 7 M20

26 February 2020

X ray, fluoroscopy systems

Model: 722079

MHRA reference: 2020/002/028/291/005

Philips: SensaVue Patient Entertainment System

05 February 2020

Magnetic resonance, equipment & accessories

Model: 9896-032-0815X – SensaVue HD 9896-032-0872X – SensaVue fMRI

MHRA reference: 2020/003/018/487/004

Philips Respironics: V60 Ventilators

March 2020

Lung ventilators

MHRA reference: 2020/003/016/487/007

Roche Diagnostics: Elecsys CA 19-9

March 2020

IVDs, clinical chemistry

MHRA reference: 2020/001/027/228/009

Siemens: Atellica CH Reaction Cuvette Segment (Update to FSN 20 – 24 January 2020)

March 2020

IVDs, clinical chemistry

MHRA reference: 2020/001/020/601/007

Thermo Fisher Scientific: Oxoid

11 March 2020

IVDs, cacteriology

Model: PB0226A

MHRA reference: 2020/003/012/601/008

Turon MedTech: CYTOGUIDE Needle guide bushes

05 February 2020

Surgical instruments, minimal access

Model: GA12, GA14, GA16, GA18, GA20, GA20 OPEN & GA22

MHRA reference: 2020/003/019/291/004

Ultramed: MyPreOp Kids

12 March 2020

Software as a medical device (SaMD)

MHRA reference: 2020/003/007/401/001

Ultramed: MyPreOp Kids 10.03.2020

12 March 2020

Software as a medical device (SaMD)

MHRA reference: 2020/003/013/487/013

UTAK Laboratories: Normal Range Trace Elements Control

17 March 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/018/701/001

16 March 2020

Osteosynthesis, nails intramedullary

MHRA reference: 2020/003/017/291/002

Updates to this page

Published 23 March 2020