Field Safety Notices - 10 - 14 October 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 10 - 14 October 2016


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: Lactic Acid

10 October 2016

IVDs, clinical chemistry

MHRA reference: 2016/010/012/701/010

Boston Scientific: Vascular Guide Catheter, single-use


Vascular cannula and catheters Model: Vascular Guide Catheter

MHRA reference: 2016/010/007/701/008

Corin: LARS

12 October 2016

Ligaments, tendons and anchors

Model: 104.002

MHRA reference: 2016/010/012/601/010

Covidien: Clearify Visualization System

October 2016

Endoscopes, flexible

Model: Clearify Visualization System

MHRA reference: 2016/010/007/701/010

Drive Medical: Able Assist

30 September 2016

Moving & handling

MHRA reference: 2016/006/021/291/016

Edwards: Edwards Commander Delivery System

August 2016

Vascular cannula and catheters

Model: 9610TF23, 9610TF26, 9610TF29

MHRA reference: 2016/005/020/701/021

GE: Brivo OEC 715/785/865

4 October 2016

X Ray, fluoroscopy systems

MHRA reference: 2016/010/010/291/007

Gabmed: gabControl D-Dimer Test

12 October 2016


MHRA reference: 2015/010/022/294/001

Greatbatch Medical:Surgical Instrument Torque Limiter

July 2016

Orthopaedic surgical instruments - Insertion/extraction tools

Model: 00-2360-080-00, 00-2360-080-05, T13621, T112972, T116430, T14378, T14379, T14380, T14000, T14001, T116245

MHRA reference: 2016/010/003/291/012

One Lambda: LABType DNA Typing Tests

29 September 2016

IVDs, immunology

MHRA reference: 2016/010/007/701/009

St. Jude Medical: Implantable Cardioverter Defibrillator

10 October 2016

Implants, active, defibrillators

Model: various as per FSN

MHRA reference: 2016/009/012/291/008

TRUMPF: Universal Arm Support

31 March 2016

Operating table Model: various as per FSN MHRA reference: 2016/010/011/701/010

Published 17 October 2016