Field Safety Notices - 13 to 17 April 2020

Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 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

AVANOS: CORFLO* PEG Kit with ENFit® Connector

07 April 2020

Feeding systems and tubes

MHRA reference: 2020/003/030/487/008

EBR System: WiSE CRT Electrode-Catheter and Delivery Sheath

14 April 2020

Implants, active, intracardiac (leadless)

Model: 1000, 2000

MHRA reference: 2020/004/015/291/002

Fast Track Diagnostics: FTD Vesicular Rash

April 2020

IVDs, bacteriology

Model: Siemens Material Number 10921714 / 10921715

MHRA reference: 2020/004/014/291/001

Philips Medical: HeartStart XL Defibrillator/Monitor

26 March 2020

Defibrillators, non implantable

Model: M4735A

MHRA reference: 2020/004/016/291/001

Philips Medical: TraumaDiagnost

17 Feb 2020

X Ray, ancillary equipment and accessories

Model: 70411, 704030, 72001, 720011, 720013, 720020, 720050

MHRA reference: 2020/004/009/487/008

Roche Diagnostics: Elecsys Troponin T hs

April 2020

IVDs, clinical chemistry

MHRA reference: 2020/004/015/291/001

SENTINEL: Immuno Control Set

February 2020

IVDs, immunology

MHRA reference: 2020/003/012/487/019

SENTINEL: Plasmaproteins Cal 3x, Plasmaproteins Cal

06 February 2020

IVDs, immunology

MHRA reference: 2020/004/016/487/004

Siemens Healthcare: Artis pheno

April 2020

X Ray, fluoroscopy systems

MHRA reference: 2020/004/014/601/002

The Binding Site: Optilite Analyser

09 April 2020

IVDs, clinical chemistry

Model: IE700

MHRA reference: 2020/004/009/601/003

Thermo Fisher Scientific: Oxoid

08 April 2020

IVDs, bacteriology

Model: PO1210A

MHRA reference: 2020/004/013/601/002

Updates to this page

Published 20 April 2020