Field Safety Notices - 28 November - 2 December 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 28 November - 2 December 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

BioMérieux: NucliSENS®

25 November 2016

IVDs, viral microbiology

Model: NucliSENS® easyMAG® Magnetic Silica, NucliSENS® Magnetic Extraction Reagents

MHRA reference: 2016/011/028/291/005

Brasseler: Patello-Femoral Joint Milling Handpiece

30 November 2016

Surgical power tools

MHRA reference: 2016/011/030/701/013

CIM med: CIM med Bottom Mounted Height Adjustable Arm

19 September2016

Monitors, patient

Model: 431A

MHRA reference: 2016/009/021/601/008

Datex-Ohmeda: Avance CS2, Avance, Amingo

FMI 34079

Anaesthetic machines and monitors

Model: 1009-9050-000, 1009-9002-000, 1009-9013-000.

MHRA reference: 2016/011/024/299/010

FUJIFILM: FUJIFILM Flexible Duodenoscope

ECN-G1636

Endoscopes, flexible

Model: ED-530XT & ED-530XT8

MHRA reference: 2016/011/025/701/009

IMPAC Medical: MOSAIQ®

November 2016

Radiotherapy

MHRA reference: 2016/011/028/701/004

Institut Straumann: see section 8 for details

ER16-0381/SB6/2016

Surgical power tools

Model: various models

MHRA reference: 2016/011/023/701/016

Laerdal: Laerdal Compact Suction Unit (LCSU4)

21 November 2016

Suction equipment

MHRA reference: 2016/011/029/701/005

Macopharma

24 November 2016

Infusion & transfusion, blood bags Model: NPT6280LA MHRA reference: 2016/011/029/701/006

Newdeal: Forefoot 1.5 set

R-HHE117

Surgical devices, non-powered

MHRA reference: 2016/011/025/299/010

Ortho Clinical: ORTHO VISION# ® and VISION# ® Max Analyzers for BioVue

December 2016

IVDs, blood transfusion

Model: 6904579 and 6904578

MHRA reference: 2016/011/024/601/004

Randox: Glucose

24 November 2016

IVDs, clinical chemistry

Model: GL364, GL366, GL1021, GL2614, GL2623

MHRA reference: 2016/011/029/601/006

Stanmore: METS Modular Tumour System

25 November 2016

Joint prosthesis, hip

Model: various

MHRA reference: 2016/011/024/701/019

Urotech: Guidewire Semislip

29 November 2016

Vascular cannula/catheter accessories

MHRA reference: 2016/011/030/291/002

Vasorum: CELT ACD Vascular Closure Device

29 November 2016

Implants, non-active, vascular haemostasis device

Model: CELT ACD Vascular Closure Device; KCLT-05; KCLT-06

MHRA reference: 2016/011/030/701/015

Wallac: DELFIA hFSH Kit and AutoDELFIA hFSH Kit

16 November 2016

IVDs, clinical chemistry

Model: A017-201 and B017-201

MHRA reference: 2016/011/016/701/012

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