Field Safety Notice - 29 October to 02 November

List of field safety notices (FSNs) from medical device manufacturers from 29 October to 02 November


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 Medical: St. Jude Medical Infinity™ DBS System (8-Channel)

01 October 2018

Implants, active, stimulators, neuro

MHRA reference: 2018/010/011/291/003

Alere (Abbott Medical): Alere BinaxNOW Legionella with the Alere Reader

November 2018

IVDs, bacteriology

MHRA reference: 2018/011/001/487/003

AngioDynamics: XCELA PASV 4F SL 55CM

16 October 2018

Vascular cannula and catheters

Model: H965557110

MHRA reference: 2018/010/029/291/016

Bard: BARD® ePTFE Small Beading Vascular Graft Products


Implants, non-active, peripheral vascular stents

MHRA reference: 2018/010/016/291/010

Biomet: Compress Devices and Instruments

31 October 2018

Orthopaedic implant intercalary component

MHRA reference: 2018/011/001/487/027

Ekamed: ekamove 30° Seitenlagerungssystem


Mattresses - active/passive and overlays

MHRA reference: 2018/010/022/291/010

GE Medical: B20, B40, Patient Monitor B125 / B105

GEHC Ref# 36132

Monitors, patient

MHRA reference: 2018/010/030/291/002


24 October 2018

Instrumentation/ platform

Model: LinkSeq HLA

MHRA reference: 2018/010/030/487/009

Magstim Company: Magstim HORIZON E-z Arm

25 October 2018

Therapy, nerve stimulators

Model: 5162-00

MHRA reference: 2018/010/029/291/059

Pennine Healthcare: BBraun Spinal Mini Pack, Pencan NRFIT 25G 88mm

01 November 2018

Injection devices

MHRA reference: 2018/007/030/228/012

Siemens: ARTIS zee

18 October 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/010/029/601/005

Siemens: Artis zee biplane and Artis Q biplane

10 October 2018

Fluoroscopy system

MHRA reference: 2018/010/029/601/004

Stryker: Spirit Plus and Spirit Select Siderail entrapment

31 October 2018

Beds and accessories

Model: 5600 - 07613327284553; 5700 - 07613327284546

5700 - 07613327284546

MHRA reference: 2018/010/022/701/015

Philips Medical: Brilliance 6 (Air), Brilliance 10 (Air), Brilliance 16 (Air), Brilliance 16 (Power), Brilliance 40,

Brilliance 64

18 October 2018

Computed Tomography

MHRA reference: 2018/010/025/487/013

Published 5 November 2018