Field Safety Notice: 27 to 31 January

List of field safety notices (FSNs) from medical device manufacturers from 27 January to 31 January 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

Abbott: Alinity ci-series System Control Module

24 January 2020

IVDs, clinical chemistry

MHRA reference: 2020/001/028/228/008

Abbott: Ellipse ICDs

22 January 2020

Implants, active, defibrillators

Model: implants, active, defibrillators

MHRA reference: 2020/001/023/228/008

Baxter Healthcare: Artiset HD DNL HC

29 January 2020

Dialysis, blood lines

Model: 955075

MHRA reference: 2020/001/028/228/012

Boule Medical AB: Medonic

02 January 2020

IVDs, haematology

Model: 1400009

MHRA reference: 2020/001/007/228/008

Chiesi: 145872-01

MD-FSN-CHIESI-2020-001

Inhaled drug delivery system

MHRA reference: 2020/001/029/121/002

Datex-Ohmeda (GE Healthcare): Giraffe Blue Spot PT Lite

GEHC Ref 32072

Therapy, adult phototherapy

MHRA reference: 2020/001/027/228/007

EDEN INNOVATIONS: DOC

26 November 2019

Defibrillators, non implantable

Model: DOC Fix and DOC Mobile

MHRA reference: 2020/001/030/487/005

FH Orthopedics: Brand

24 October 2019

Orthopaedic surgical instruments - cutting tools

MHRA reference: 2020/001/030/487/003

Intelerad Medical Systems Incorporated: IntelePACS

21 January 2020

Picture archiving and communication system (PACS)

MHRA reference: 2020/001/022/701/001

LaproSurge: 5mm curved scissors, L330mm/blade L17mm

16 January 2020

Surgical instruments, articulated cutting

Model: LS001

MHRA reference: 2020/001/020/487/001

Medtronic: HeartWareTM Battery Charger AC Adapter

January 2020

Implantable Ventricular Assist Devices

Model: 1610, 1640

MHRA reference: 2020/001/030/487/002

Mindray Building: Patient Monitors

January 2020

Monitors, patient

Model: VS-900, N12, N15, N17, N19

MHRA reference: 2020/001/015/291/006

Philips Healthcare: Efficia Combined Cable/3 and 5 Leadset

December 2019

Therapy, electrotherapy

Model: See FSN

MHRA reference: 2020/001/028/228/013

Roche Diagnostics: Elecsys CA 19-9

January 2020

Reagent/ assay

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

Roche Diagnostics Cobas e 801: Elecsys Troponin T hs.

January 2020

IVDs, clinical chemistry

Model: Cobas e 801

MHRA reference: 2019/010/030/701/035

Siemens Healthcare: Artis pheno

23 January 2020

X Ray, general

MHRA reference: 2020/001/024/601/004

Stryker: LIFEPAK® 15 Monitor/Defibrillator

January 2020

Defibrillators, non implantable

Model: See FSN

MHRA reference: 2020/001/013/228/007

Stryker: SPY-PHI Drape

January 2020

Surgical drapes, gowns, masks

MHRA reference: 2020/001/023/291/001

Published 4 February 2020