Field safety notices - 18 to 22 May 2015

List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2015.


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

Abbott Laboratories: Abbott Clinical Chemistry Alkaline Wash

11 May 2015

IVDs, clinical chemistry

MHRA reference: 2015/005/014/701/001

ArcRoyal: Covidien Devon light gloves (light handle covers)

13 May 2015

Surgical devices, non-powered

MHRA reference: 2015/005/020/701/004

Biotronik: Pulsar-18 & Pulsar-35 (200mm length only)

May 2015

Implants, non-active, peripheral vascular stents

MHRA reference: 2015/005/014/701/002

Boston Scientific: RELIANCE 4-FRONT™ single coil defibrillation lead

19 May 2015

Implants, active, leads and electrodes

MHRA reference: 2015/005/015/291/001

Elekta: Leksell GammaPlan



Model: 1028541

MHRA reference: 2015/005/018/291/012/01

GBUK Healthcare: Safe-T-Vac wound drainage system

12 May 2015

Wound drains

MHRA reference: 2015/005/013/291/002

Janssen Diagnostics LLC: CellSearch circulating tumour cell kit (epithelial)

20 May 2015

IVDs, cytopathology & histopathology

Model: 79900001(IVD)

MHRA reference: 2015/005/021/291/004

HeartWare: HeartWare Ventricular Assist System

08 May 2015 (FSCA APR2015B)

Implantable ventricular assist devices

Model: ASY00116 & ASY00281

MHRA reference: 2015/005/018/291/004

HeartWare: HeartWare Ventricular Assist System

08 May 2015 (FSCA APR2015A)

Implantable ventricular assist devices

Model: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205

MHRA reference: 2015/005/018/291/005

Medtronic Ltd

19 May 2015

Airway devices

Model: Shiley tracheostomy tubes, various

MHRA reference: 2015/005/019/131/002


27 April 2015

IVDs, extra laboratory testing

Model: GD7046, GD7013, GD7045, GD7031

MHRA reference: 2015/004/015/701/011

Ortho Clinical Diagnostics: ORTHO VISION™ Analyzer

May 2015

IVDs, blood transfusion

Model: 6904579

MHRA reference: 2015/005/018/601/011

PerkinElmer: WIZARD2 Gamma Counter

13 May 2015

IVDs, clinical chemistry

MHRA reference:2015/005/019/291/012

RaySearch Laboratories: radiation therapy treatment planning system

8 May 2015

Radiotherapy planning and verification systems

Model: RayStation04

MHRA reference: 2015/005/019/131/001

Sekisui Diagnostics: acetaminophen assay (mulitgent)

05 May 2015

IVDs, clinical chemistry

MHRA reference: 2015/005/011/291/001

May 2015 (ISW 15-02)

IVDs, clinical chemistry

MHRA reference: 2015/005/021/601/005

Siemens Healthcare Diagnostics: Dimension Vista

May 2015 (VSW 15-03)

IVDs, clinical chemistry

Model: Dimension Vista 500, Dimension Vista 1500

MHRA reference: 2015/005/021/601/003

Siemens Healthcare Diagnostics: ADVIA Centaur TnI-Ultra

May 2015

IVDs, clinical chemistry

MHRA reference: 2015/005/020/601/004

Unomedical: Paradigm Sure-T

20 May 2015

Infusion and transfusion, administration sets

Model: MMT-866

MHRA reference: 2014/007/002/081/042

Vascutek: Gelseal

15 May 2015

Implants, non-active, surgical vascular grafts and patches

Model: Gelseal Straight

MHRA reference: 2015/005/015/291/018

Zimmer, Inc: cortical screws / M/DN® intramedullary fixation

19 May 2015

Osteosynthesis, bone screws

MHRA reference: 2015/005/020/701/002

Published 22 May 2015