Field Safety Notices - 1 - 5 August 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 1 - 5 August 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 Vascular: Absorb and Absorb GT1

27 July 2016

Implants, non-active, coronary artery stents

MHRA reference: 2016/008/004/291/001

Alcon Laboratories: AcrySof IQ IOL with ULTRASERT™ delivery system

29 July 2016

Implants, non-active, intraocular

MHRA reference: 2016/008/001/299/008

Beckman Coulter: DxH 500

27 July 2016

IVDs, haematology

MHRA reference: 2016/007/027/601/009

BIOMERIEUX: Etest Colistin CO 0.016-256

1 August 2016

IVDs, bacteriology MHRA reference: 2016/008/001/299/006

Esaote: MyLab Twice/Esaote/Esaote

10 March 2016 Ultrasound, imaging Model: 9706200000

MHRA reference: 2016/007/011/291/002

Esaote: Gscan Brio/Esaote/Esaote

18 April 2016 Magnetic resonance, equipment & accessories Model: 111002000

MHRA reference: 2016/007/011/291/001

Maquet: Fixture

19 July 2016

Operating table Model: 1002.65A0

MHRA reference: 2016/007/020/701/001

Medtronic: EnVeo R delivery catheter system

August 2016

Implants, non-active, cardiovascular heart valves


MHRA reference: 2016/008/004/299/003

Mölnlycke Health Care AB: ProcedurePak kits and trays containing umbilical clamps

28 July 2016

Surgical devices, non-powered

MHRA reference: 2016/008/005/701/009

Nobel Biocare: NobelParallel CC guided surgery kit

03 August 2016

Surgical devices, non-powered Model: 38072

MHRA reference: 2016/007/022/701/010


August 2016

Defibrillators, non-implantable Model: 3202359-XXX and 3202177-XXX

MHRA reference: 2016/008/003/299/011

Siemens AG: Assembly group table of Ysio, Ysio Max and Multix Fusion

UI XP022/16/S & UI XP023/16/S & UI XP026/16/S

X-ray, digital acquisition systems

Model: 10273106 and 10273107

MHRA reference: 2016/008/001/601/003

Siemens Healthcare Diagnostics: ADVIA Centaur PSA

July 2016

IVDs, clinical chemistry

Model: SMN 10310292, SMN 10310293

MHRA reference: 2016/008/001/601/001

Tem Innovations: ROTEM platelet cuvettes (art. No. 200188)

23 March 2016

IVDs, haematology MHRA reference: 2016/005/003/299/009

Published 8 August 2016