Field Safety Notices: 21 to 25 January 2019

List of field safety notices (FSNs) from medical device manufacturers from 21 to 25 January 2019

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

BIOMERIEUX

17 January 2019

IVDs, bacteriology

MHRA reference: 2019/001/018/487/008

CME McKinley: T34 Syringe Driver

January 2019

Infusion systems

MHRA reference: 2019/001/024/487/009

Cook Medical: Brand

08 January 2019

Urinary catheters and accessories

guidewire

MHRA reference: 2019/001/014/701/028

Dako: Dako Slide Racks

17 January 2019

IVDs, cytopathology & histopathology

MHRA reference: 2019/001/017/487/021

GE: Centricity Universal Viewer

GEHC Ref# 85448

Picture Archiving and Communication System (PACS)

MHRA reference: 2019/001/022/291/008

Medtronic: Adapta™, Versa™, Sensia™, Relia™, Attesta™, Sphera™, and Vitatron™ A, E, G, Q series Implantable Pulse Generators (IPG)

January 2019

Implants, active, pacemakers

Distributed between 10 March 2017 and 7 January 2019

MHRA reference: 2019/001/018/291/003

January 2019

Implants, active, cardiac programmers and remote monitoring

MHRA reference: 2019/001/022/291/001

Natus: neoBLUE blanket Phototherapy LED System

December 2018

Therapy, infant phototherapy

MHRA reference: 2016/012/007/701/010

Philips: Philips Efficia Monitors (CM10/12/100/120/150)

18 December 2018

Monitors, patient

The affected products are all Efficia CM Monitors manufactured before Oct 25, 2018 that are capable of operating under battery power and have lithium-ion batteries presently installed

MHRA reference: 2019/001/021/487/001

Terumo: HydroPearl® microspheres

18 January 2019

Implants, non-active, embolisation products

8HP2S600

MHRA reference: 2019/001/021/701/013

Thermo Fisher: Oxoid

22 January 2019

IVDs, bacteriology

Model: PB1229A

MHRA reference: 2019/001/022/601/004

Updates to this page

Published 28 January 2019