Field safety notices - 11 to 15 January 2016

List of field safety notices (FSNs) from medical device manufacturers from 11 January to 15 January 2016.

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. See more information on what an FSN is and why it’s important.

Latest FSNs

View the latest FSNs

bioMérieux: API ® ZYM Bx2

January 2016

IVDs, bacteriology

MHRA reference: 2016/001/007/181/001

BrainLAB: brain metastases, adaptive hybrid surgery analysis

15 December 2015

Radiotherapy planning and verification systems

MHRA reference: 2016/001/008/292/011

Cook Medical: central venous catheters

6 January 2016

Vascular cannula and catheters

MHRA reference: 2016/001/012/292/015

CVRx: Barostim Neo

6 January 2016

Therapy, electrotherapy

Model: Barostim Neo 2102 & 9010

MHRA reference: 2016/001/007/601/017

DePuy Orthopaedics Worldwide - Ireland: SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument

January 2016

Surgical instruments, implant

MHRA reference: 2015/012/023/291/001

Draeger: Oxylog 3000, Oxylog 3000 plus and Oxylog 2000 plus

November 2015

Lung ventilators

MHRA reference: 2015/012/021/291/007

Ellipse A/S: Ellipse Nordlys, 9SYS7751 w/HRL 600 Applicator/handpiece

5 November 2015

Therapy, lasers

MHRA reference: 2015/012/022/291/013

Fresenius Medical Care AG: Enteral Nutrition ENfit Giving Set

6 January 2016

Feeding systems and tubes

MHRA reference: 2016/001/008/292/013

Philips Healthcare Inc: IntelliVue patient monitor

December 2015

Monitors, patient

Model: M3001A IntelliVue Measurement Module X1

MHRA reference: 2016/001/014/292/023

H-p-cosmos: h/p/cosmos treadmill

10 December 2015

Diagnostic measurement and monitoring

MHRA reference: 2016/001/005/292/019

Infomed: HF440

26 August 2015

Dialysis, haemofilters

Model: HF440

MHRA reference: 2015/009/017/081/005

Mavig: monitor suspension system GD60

11 January 2016

X-ray, fluoroscopy systems

Model: GD60-4-GE

MHRA reference: 2016/001/012/292/004

Smith & Nephew: BEAVER 4.0mm Banana Blade

14 January 2016

Surgical instruments, non-articulated cutting

MHRA reference: 2016/001/014/292/025

TRUMPF Medizin Systeme: TruLight 3000, TruLight 5000, iLED 3, iLED 5, TruV

January 2016

Lamps and lights

Model: TruLight 3000, TruLight 5000, iLED 3, iLED 5, TruV 4028110

MHRA reference: 2016/001/008/292/010

Zimmer: NexGen PRI femoral impactor head

22 May 2015

Joint prosthesis, hip

MHRA reference: 2015/005/028/071/001

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