Field Safety Notice: 18 to 22 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 18-22 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

Becton Dickinson: Alaris ™ VP Plus with Guardrails™

01 January 2019

Infusion systems

Model: 9003MED01-G, 9003TIG01-G, 9003TIG03-G

MHRA reference: 2019/002/018/487/009

GeneOhm Sciences (Becton Dickinson): BD MAX™ Enteric Bacterial Panel

11 February 2019

IVDs, bacteriology

MHRA reference: 2019/002/014/228/008

Elcon Medical Instruments: Laparoscopic handle with HF-connection (w or w/o r

14 February 2019

Surgical instruments, articulated holding

MHRA reference: 2019/002/019/487/010

GE Healthcare: Carescape R860

GEHC ref# 34095-A

Lung ventilators

MHRA reference: 2019/002/015/701/018

GE Medical Systems: Carescape One

GEHC ref# 36136

Monitors, patient

MHRA reference: 2019/002/019/701/016

Maquet (Getinge): Pre-Bypass Filter

18 February 2019

Infusion & transfusion, heart lung circuits

Model: 70102.1039; 70102.1040; 70103.1084; 70103.1086

MHRA reference: 2019/002/019/487/029

Marquardt: Staple Ø 1.0mm, 90°

13 February 2019

Osteosynthesis, skeletal pins, wires & staples

Model: 12.91009.012S

MHRA reference: 2019/002/019/487/012

Sequent Medical: WDC - WEB (R) Detachement Controller

14 February 2019

Implants, non-active, embolisation products Model: WDC-1

MHRA reference: 2019/002/019/487/024

Siemens Healthcare: UROSKOP OMNIA and UROSKOP OMNIA MAX

UI XP004/19/S (FSN) and XP006/19/S (FSCA)

X Ray, fluoroscopy systems

Model: 10094910 and 10762473

MHRA reference: 2019/002/013/601/005

Siemens Healthcare: Enzygnost Syphilis

January 2019

IVDs, bacteriology

MHRA reference: 2019/002/018/487/006

Stanmore: Femoral Heads

18 February 2019

Joint prosthesis, hip

Model: msfmh/cc28-3.5

MHRA reference: 2019/002/019/487/019

Tristel Solutions: TRISTEL DUO ULT

18 February 2019

Sterilization, healthcare

TSL022601

MHRA reference: 2019/002/019/601/001

X-spine Systems (Xtent): Calix Lumbar Spinal Implant System

01 September 2018

Spinal implants

Model: Please see FSN

MHRA reference: 2019/001/031/701/002

Updates to this page

Published 25 February 2019
Last updated 26 February 2019 + show all updates
  1. Added correct link for the Stanmore: Femoral Heads FSN

  2. First published.