Field Safety Notice - 26 to 30 June 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 June 2017

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

AlterG: Anti-Gravity

26 June 2017

Therapy, standing & walking

Model: M320

MHRA reference: 2017/006/027/291/023

Bio-Rad Laboratories: ID-DiaCell's

03 May 2017

IVDs, blood transfusion

MHRA reference: 2017/002/013/291/011

Biomet: ExploR 6x24mm Implantable Stem with Screw

28 June 2017

Joint prosthesis, elbow

MHRA reference: 2017/006/029/291/015

Boston Scientific Corporation: Encore™ 26 Inflation Device

20 June 2017

Vascular cannula/catheter accessories

Model: H74904526011, M001151050, M00566670,

M0067101140

MHRA reference: 2017/006/019/291/015

CellaVision: DI-60

16 June 2017

IVDs, haematology

MHRA reference: 2017/006/028/291/003

Cook: Vue Optic Visualization Source Flexor Vue Deflecting Endoscopic System

07 June 2017

Endoscopes, televisual systems

MHRA reference: 2017/006/013/291/017

Cook Medical: Zenith Alpha™ Thoracic Endovascular Graft

June 2017

Implants, non active, endoprostheses for aortic aneurysms

Model: Zenith Alpha™ Thoracic Endovascular Graft

MHRA reference: 2017/006/026/291/014

DePuy Synthes

21June 2017

Osteosynthesis, bone screws

Model: 04.511.635.04S, 04.511.666.04S, 04.511.226.04S

MHRA reference: 2017/006/023/291/014

GE Healthcare: Centricity™ High Acuity Critical Care

FMI 85440

Monitors, patient

MHRA reference: 2017/006/026/291/008

HOYA: PENTAX ULTRASOUND UPPER GI VIDEOSCOPES

26 June 2017

Endoscopes, flexible

Model: EG-3870UTK and EG-3670URK

MHRA reference: 2017/006/019/291/035

Helena BioSciences: APTT Si L Minus, APTT (SILICA) 5558SLQ, 5559SLQ, 5560SLQ, 5562SLQ, OQLS493502, OQLS955502

23 June 2017

Coagulation

MHRA reference: 2017/006/023/601/006

Hitachi High Technologies Corporation

21 June 2017

IVDs, clinical chemistry

Model: cobas e 411 (disk system), Model No. 04775279001

cobas e 411 (rack system), Model No. 04775201001

Elecsys 2010 analyzer (disk system), Model No. 11568248001

Elecsys 2010 analyzer (rack system), Model No. 11804014001

cobas e 411 (disk system), Model No. 04775279001

cobas e 411 (rack system), Model No. 04775201001

Elecsys 2010 analyzer (disk system), Model No. 11568248001

Elecsys 2010 analyzer (rack system), Model No. 11804014001

MHRA reference: 2017/006/023/701/006

Hologic: Tomcat Instrument

4475396

IVDs, cytopathology & histopathology

MHRA reference: 2017/006/026/601/009

Joerns Healthcare: Oxford Dipper

000017

Hoists and slings

MHRA reference: 2017/003/029/299/020

Medtronic: 11001G - DLP® Extension Line Adapters 20 in length; 13001 - DLP® Antegrade/Retrograde Adapter;

15004 - DLP® Cardioplegia Adapter with Pressure Port; 25009 - DLP® Pressure Monitoring Extension Line Adapters; 25010 - DLP® Pressure Monitoring Extension Line Adapters; 61000 - DLP® Pressure Disposable Pressure Display Sets; 62000 - DLP® Pressure Disposable Pressure Display Sets

23 June 2017

Infusion & transfusion, heart lung circuits

MHRA reference: 2017/006/026/291/010

NBS Reagents: Titration cells cell 1

22 June 2017

IVDs, blood transfusion

Model: R407 5188

MHRA reference: 2017/006/023/601/007

Orthofix: POWER DRILL TORQUE LIMITER

28 June 2017

Osteosynthesis, external fixators

Model: 99-93568

MHRA reference: 2017/006/029/291/003

Prism: Freeway Easyfit System

28 June 2017

Hoists and slings

Model: 1102PHATPEF

MHRA reference: 2017/006/027/601/007

QIAGEN: QIAamp DSP Virus Kit

22 June 2017

IVDs, viral microbiology

Model: QIAamp DSP Virus Kit

MHRA reference: 2017/006/023/701/008

Thermofisher Scientific: ThermoScientific Oxoid GC Agar

29 June 2017

IVDs, bacteriology

Model: CM0367

MHRA reference: 2017/006/029/601/006

Published 3 July 2017