Field safety notices - 25 April to 29 April 2016

List of field safety notices (FSNs) from medical device manufacturers from 25 April to 29 April 2016


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

Alcon Laboratories: LenSx Laser System

22 April 2016

Therapy, lasers

MHRA reference: 2016/004/022/299/017

B Braun Medical: DPO4000L DISPENSING PIN W/ ULTRASITE 412023

25 April 2016

Infusion & transfusion, connectors

MHRA reference: 2016/004/021/601/014

Bard: EnCor Biopsy Probe, Vertical


Surgical instruments, minimal access

MHRA reference: 2016/004/022/601/008

BioFire Diagnostics: FilmArray Blood Culture Identification Panel-BCID

1604 FilmArray BCID Panel

IVDs, bacteriology

MHRA reference: 2016/004/022/701/014

Biomet: Tyvek pouch for various sports medicine and trauma products

01 April 2016

Central sterilisation services materials

MHRA reference: 2016/004/021/291/009

Biomet: Distal Plug

22 April 2016

Surgical instruments -impacting tools

MHRA reference: 2016/004/027/299/001

Carestream: CARESTREAM Image Suite

22 April 2016

Picture Archiving And Communication System (PACS) MHRA reference: 2016/004/022/299/014

Cook Medical: Beacon Tip Angiographic Catheters


Vascular cannula and catheters

MHRA reference: 2016/004/027/299/008

Cook Medical: FluoroSet® Radiographic Tubal Assessment Set, Selective Salpingography Catheter with Beacon® Tip Kumpe Access Catheter

21 April 2016

Vascular cannula and catheters

MHRA reference: 2016/004/022/291/009

GE Medical

26 April 2016

X Ray, Fluoroscopy Systems

Model: Discovery IGS 730, Discovery IGS 740

MHRA reference: 2016/004/027/299/007

Optimed: Zelos PTA-balloon catheter

25 April 2016

Vascular cannula and catheters

MHRA reference: 2016/004/021/701/007

Oridion Medical 1987: Battery Pack Used with the Capnostream™20 and Capnostream™20p Patient Monitor.

25 April 2016

Monitors, patient

MHRA reference: 2016/004/022/299/001

Phadia: EliA CCP Positive Control

21 April 2016

IVDs, immunology

MHRA reference: 2016/004/026/601/003

Philips: IntelliSpace Portal

06 March 2016

Computed tomography

Model: IntelliSpace Portal 881001

MHRA reference: 2016/003/018/292/004

Philips Medical: Brilliance BR64 Ingenuity CT Ingenuity Core Ingenuity Core128 Brilliance iCT SP Brilliance iCT

19 April 2016

Computed tomography

Model: Brilliance BR64 (728231) Ingenuity Core (728321) Ingenuity Core128 (728323) Ingenuity CT (728326) Brilliance iCT SP – N/A Brilliance iCT – NCTC780

MHRA reference: 2016/004/026/291/010

Philips Medical: MobileDiagnost wDR

04 April 2016

X Ray, digital acquisition systems

Model: 712002

MHRA reference: 2016/004/026/291/009

Roche: AssayTip / AssayCup

26 April 2016

IVDs, clinical chemistry

MHRA reference: 2016/004/027/701/010

Spacelabs Healthcare: Xhibit Telemetry Receiver

28 March 2016

Monitors, patient

Model: 96280

MHRA reference: 2016/004/020/299/004


April 2016

Gas cylinders

Model: Several

MHRA reference: 2016/004/008/701/006

William Cook Europe


Vascular cannula and catheters

MHRA reference: 2016/004/027/299/009

Published 3 May 2016