Field Safety Notice - 18 to 22 June 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 June 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

Becton Dickinson: All Alaris Syringe Driver models

June 2018

Infusion systems

MHRA reference: 2018/006/020/081/027

Boston Scientific: Maestro Cardiac Ablation System

20 June 2018

Therapy tissue ablation

Model: Maestro 4000 Footswitch: M004218500- Maestro 4000 Footswitch M00421850D0- Maestro 4000 Footswitch, Demo M00421850H0- Maestro 4000 Footswitch, Hospital Owned M00421850R0- Maestro 4000 Footswitch, Repaired M00421850Z0- Maestro 4000 Footswitch, Zero Cost Maestro Pump to Generator Cable: M004315000- Cable OI Pump to OI Maestro Maestro 4000 Controller: M00440000- Maestro 4000 Controller M0044000D0- Maestro 4000 Controller, Demo M0044000H0- Maestro 4000 Controller, Hospital Owned M0044000R0- Maestro 4000 Controller, Repaired M0044000Z0- Maestro 4000 Controller, Zero Cost

MHRA reference: 2018/006/020/291/012

CareFusion: Airlife™ Manual Resuscitator

June 2018

Resuscitators

MHRA reference: 2018/006/018/291/007

Ethicon:Ultrasonic Surgical System Handpiece Tip

2 May 2018

Surgical power tools

MHRA reference: 2018/005/009/478/001

Fukuda Densh: Fukuda Denshi ECG Trolley

6 April 2018

Trolleys and chairs

Model: OTE-02

MHRA reference: 2018/004/017/601/008

GE Medical Systems: Discovery MR750w

GEHC Ref 60937

Magnetic resonance, equipment & accessories

MHRA reference: 2018/006/019/291/029

Leica: Bond

IR27/18

IVDs, cytopathology & histopathology

Model: DS9800

MHRA reference: 2018/006/014/601/011

Leica: HistoCore Spectra ST

June 2018

IVDs, cytopathology & histopathology

Model: 14051254354

MHRA reference: 2018/006/007/291/002

Medicrea International: IMPIX MANTA prefilled on holder

13 June 2018

Spinal implants

Model: B20171743, B20171963, B20171973

MHRA reference: 2018/006/018/291/020

Medline Industries: Bocal d'aspiration MED-RIGID 2L

12 June 2018

Surgical equipment, miscellaneous

MHRA reference: 2018/006/014/291/002

Philips Healthcare (IGT System): Allura Xper, UNIQ, and Centron

22 June 2018

X Ray, fluoroscopy systems

MHRA reference: 2018/006/019/291/016

Philips Medical: Patient support

21 March 2018

X Ray, general

Model: 989001087431

MHRA reference: 2018/006/020/081/031

Radiometer: TCM5 Calibration Gas

FAN 915-379

Monitors, foetal

MHRA reference: 2018/003/014/228/004

Smith & Nephew: Journey Oxinium Knee

13 June 2018

Joint prosthesis, knee

MHRA reference: 2017/009/007/264/002

Smith & Nephew: SUTURE ANCHOR DEVICES

04 June 2018

Sutures

MHRA reference: 2018/006/005/478/012

Smith & Nephew: Legion HK Tibial Base SZ 5 Left

R-2018-25

Joint prosthesis, knee

MHRA reference: 2018/006/019/701/008

St. Jude Medical: CardioMems Hospital and Patient Electronic System

14 June 2018

Implants, active, monitors and recorders

Model: CardioMems Hospital and Patient Electronic System CM3000, CM1100

MHRA reference: 2018/006/013/291/001

WG Healthcare: CT011, CT012, MI Screw

10 May 2018

Osteosynthesis, bone screws

MHRA reference: 2014/006/012/401/003

Published 25 June 2018
Last updated 27 June 2018 + show all updates
  1. Inserted Philips Healthcare (IGT System): Allura Xper, UNIQ, and Centron
  2. First published.