Field Safety Notices - 30 May - 3 June 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 30 May - 3 June 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

Beckman Coulter: ALT (OSR6x07) and Glucose STAT (OSR6x40)

31 May 2016

IVDs, clinical chemistry MHRA reference: 2016/005/031/601/005

Drägerwerk: VentStar Oxylog3000F (P) 190

May 2016

Breathing system components

MHRA reference: 2016/005/026/291/008

FUJIFILM: Fujifilm Synapse PACS

19 May 2016

Picture Archiving and Communication System (PACS)

MHRA reference: 2016/005/018/291/015

Immucor: LIFECODES HLA-C eRES SSO Typing Kit

29 April 2016

IVDs, immunology MHRA reference: 2016/005/027/701/010

Kimal: Introducer needle 18G

27 May 2016

Injection devices

Model: K6/1

MHRA reference: 2016/005/027/601/007

Mathys: Affinis implants with Ti/CaP coating

May 2016

Joint prosthesis, shoulder Model: 60.21.0000; 60.21.0001; 60.30.3150; 60.30.3151; 60.30.6390; 60.30.6393; 60.30.6420; 60.30.6423; 62.34.0010; 62.34.0011; 62.34.0012; 62.34.0013; 62.34.0014; 62.34.0015

MHRA reference: 2016/006/001/701/002

31 May 2016

Implants, active, monitors and recorders Model: 24950

MHRA reference: 2016/005/027/299/003

RaySearch Laboratories: RayStation

24 May 2016

Radiotherapy planning and verification Model: RayStation 5

MHRA reference: 2016/006/001/291/009

Roche: Accu-Chek Insight System

SB_RDC_2016_07

Infusion systems

MHRA reference: 2016/006/001/701/009

Siemens: ADVIA Centaur XPT System

31 May 2016

IVDs, clinical chemistry MHRA reference: 2016/006/001/601/008

Smith & Nephew: Legion Hinge Knee Femoral Assembly

26 May 2016

Joint prosthesis, knee MHRA reference: 2016/005/027/291/008

Smith & Nephew: Allevyn Cavity 9cm X 2.5cm Tubular Wound Dressings

20 May 2016

Basic dressings, absorbents, swabs, procedure packs

Model: Small tubular

MHRA reference: 2016/006/002/291/001

Stanmore: METS Femoral Plateau Plate

31 May 2016

Joint prosthesis, knee MHRA reference: 2016/006/001/291/015

Sysmex Corporation Sysmex Corporation: FLUOROCELL PLT

27 May 2016

IVDs, haematology

MHRA reference: 2016/006/001/299/005

iMDsoft: MetaVision Suite, Clinical Information System&EHR

May 2016

Monitors, patient

MHRA reference: 2016/006/001/291/011

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