Field Safety Notice - 14 to 18 May 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 May 2018.

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

ArjoHuntleigh: Akron Tilt Table

FSN-POZ-002-2018

Trolleys and chairs

Model: A8652, A8652T

MHRA reference: 2018/005/011/601/003

Datascope (Getinge)

04 May 2018

Cardiac assist pumps

Model: Circulatory assist system, intra-aortic balloon

MHRA reference: 2018/005/010/228/001

Gambro (Baxter): Prismaflex System

May 2018

Dialysis, haemofilters

Model: 107493

MHRA reference: 2018/005/016/291/010

Immucor: Panocell-10 Ficin Set 23x3,1x2

23 January 2018

IVDs, blood transfusion

Model: 0002385

MHRA reference: 2018/005/017/291/004

Implant Direct: Legacy™ Implant Closed‐Tray Transfer-Concave

May 2018

Implants, dental

Model: 8735-05

MHRA reference: 2018/005/017/601/001

Intuitive Surgical: EndoWrist Stapler Release Kit

ISIFA2017-02-C Phase II

Endoscopes, rigid

Model: 381215-03; 381381-02; 381382-02; 381383-02; 381384-02; 381385-02; 381386-02; 381387-02; 381388-02; 381389-02; 381393-02; 381395-02; 381401-02; 381402-02; 381403-02

MHRA reference: 2018/005/018/478/018

Ortho Clinical Diagnostics: VITROS Chemistry Products PHYT Slides

10 May 2018

IVDs, clinical chemistry

Model: 8298671

MHRA reference: 2018/005/013/601/001

Philips: FlexCardio

December 2017

Monitors, patient

Model: 722458 & 722459 Flex Cardio

MHRA reference: 2018/005/015/478/001

Philips: OmniDiagnost Classic & Eleva

01 May 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/005/011/478/010

Siemens Healthcare: N Latex CDT Kit

May 2018

IVDs, clinical chemistry

MHRA reference: 2018/005/017/701/002

Teleflex (Arrow International): Various

09 May 2018

Vascular cannula and catheters

MHRA reference: 2018/005/011/478/009

Updates to this page

Published 24 May 2018