Field Safety Notice: 11 to 15 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 February 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

Babylon Health:Chatbot Online Doctor

13 February 2019

Diagnostic / therapeutic software algorithm

MHRA reference: 2018/005/016/291/021

Cepheid: Xpert® HBV Viral Load

08 February 2019

IVDs, Viral Microbiology

MHRA reference: 2019/002/013/701/013

Cordis: Cordis Vista Brite and ADROIT Guiding Catheter

07 February 2019

Vascular cannula and catheters

MHRA reference: 2019/002/008/487/033

Depuy Synthes: REEF™ Cementless Metaphyso-Diaphyseal Femoral Stem

February 2019

Joint prosthesis, hip

MHRA reference: 2019/002/008/487/009

GE Healthcare: CHA Anesthesia and CHA Critical Care

38000

Anaesthetic Machines & Monitors

MHRA reference: 2019/002/013/228/004

IBL International GmbH: DHEA ELISA

11 February 2019

IVDs, clinical chemistry

MHRA reference: 2019/002/012/701/011

Randox Laboratories: Blood Gas Controls Levels 1,2,3

05 February 2019

IVDs, extra laboratory testing

Model: BG5001 BG5002 BG5003

MHRA reference: 2019/002/012/601/002

Randox Laboratories:RX Modena

06 February 2019

IVDs, clinical chemistry

Model: RX9000

MHRA reference: 2019/002/012/601/006

Siemens (Advia): ADVIA Chemistry

February 2019

IVDs, clinical chemistry

MHRA reference: 2019/002/008/601/005

Siemens (Vista): Dimension Vista® Lactate Dehydrogenase (LDI)

October 2018

IVDs, clinical chemistry

Model: SMN 10464323

MHRA reference: 2019/002/008/601/004

Smith's Medical (Protect):ProtectIV Plus Safety IV Catheter

08 February 2019

Vascular cannula and catheters

MHRA reference: 2019/002/011/487/003

Smith's Medical (Portex): Portex® Blue Line Ultra® Tracheostomy Tubes

11 February 2019

Airway devices

Model: 100/856/080

MHRA reference: 2019/002/012/487/034

Stryker: LIFEPAK 15 monitor/defibrillator

06 February 2019

Defibrillators, Non-Implantable

V15-2-000XXX

MHRA reference: 2019/002/004/291/012

Swemac Innovation AB: Motec Wrist Prosthesis

22 January 2019

Joint prosthesis, misc

Model: 40-1015S Motec Wrist Prosthesis

MHRA reference: 2019/002/011/601/002

WEST Pharma. Services IL: Vial2Bag Needleless Transfer Device

28 January 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/002/001/487/010

Updates to this page

Published 18 February 2019
Last updated 18 February 2019 + show all updates
  1. Added FSN for Stryker: LIFEPAK 15 monitor/defibrillator

  2. First published.