Field Safety Notices - 21 - 25 November 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 21 November - 25 November 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.

Latest FSNs

View the latest FSNs

Acutronic Medical Systems AG: fabian HFO and fabian evolution

15 November 2016

Lung ventilators

Model: 7200, 7200J, 7201, 7250, 7250.

MHRA reference: 2016/011/024/299/021

Alere

29 August 2016

Coagulation

Model: INRatio and INRatio2 monitors and test strips

MHRA reference: 2016/004/019/294/001

APELEM: Platinum dRF

18 November 2016

X Ray, General

MHRA reference: 2016/011/024/701/013

Biomet: Optipac @ Bone Cement

15 November 2016

Bone, cement and tools

MHRA reference: 2016/011/021/701/002

Bosch + Sohn

13 October 2016

Monitors, blood pressure

Model: 24h Ambulatory blood pressure monitor

MHRA reference: 2016/011/008/299/003

Domain Surgical: FMsealer Open Shears

27 October 2016

Surgical, diathermy

Model: FM3001

MHRA reference: 2016/011/018/601/010

Greatbatch: Offset Reamer Handle

3004976965-10/10/16-003-R

Surgical Instruments, non-articulated cutting

Model: T5766

MHRA reference: 2016/011/022/701/022

Handicare: Carina35OEM Carina 35OEML Carina 3SOEE

20 July 2016

Hoists and slings

Model: 60600011, 60600012, 60600009

MHRA reference: 2016/007/022/299/009

Invacare: Birdie

13 September 2016

Hoists and slings

Model: Birdie all models

MHRA reference: 2016/008/031/291/012

Maquet: Maquet Heater and Maquet Heater/Cooler Systems

15 November 2016

Blood/fluid warming systems

Model: HU35

MHRA reference: 2016/011/023/701/012

Radiometer Medical: AQURE system

FAN 915-358

IVDs, extra laboratory testing

Model: AQURE system

MHRA reference: 2016/011/018/291/009

Roche Diagnostics: Please see below under "Accessories"

15 November 2016

IVDs, extra laboratory testing

Model: cobas b 123 <3> POC system /cobas b 123 <4> POC system

MHRA reference: 2016/011/017/701/011

Smith & Nephew: Modular Neck Hip Prostheses

R-2016-48

Joint prosthesis, hip

MHRA reference: 2016/011/017/701/007

Smith & Nephew: Reflection Dead Blow Mallet

16 November 2016

Surgical devices, non-powered

MHRA reference: 2016/011/018/701/004

Siemens:IMMULITE 1/1000 IMMULITE 2000 PSA

November 2016

IVDs, immunology

MHRA reference: 2016/011/021/601/009

Siemens: EMIT® Ethosuximide assay

22 November 2016

IVDs, bacteriology

Model: 6E119UL

MHRA reference: 2016/011/023/601/002

Sunrise Medical: Trophy

October 2016

Scooters, powered

MHRA reference: 2016/001/026/292/023

Teleflex Medical: Visistat Skin Stapler 35 Wide (35W)

21 November 2016

Staples and staple guns

Model: 528235

MHRA reference: 2016/011/022/299/016

Völker GmbH:Nursing beds 2080, 2082, S 280, S 282

IT1019961

Beds and accessories

Model: 2080, 2082, S 280, S 282

MHRA reference: 2016/005/025/299/014

Xiros: Infinity-Lock implant set and disposable instrument se

22 November 2016

Orthopaedic surgical instruments - insertion/extraction tools

Model: 102-1088 and 202-1088

MHRA reference: 2016/011/022/601/005

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