Field safety notices - 11 to 15 May 2015

List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 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

Beaver Visitec International: BVI CustomEyes ophthlamic procedure kits

5 May 2015

Lamps and lights

MHRA reference: 2015/005/005/291/030

Beaver Visitec International: BVI viscoelastic solutions

6 May 2015

Implants, non active, intraocular

MHRA reference: 2015/005/006/291/011

Biomet: Optigun Ratchet

9 April 2015

Surgical instruments, implant

MHRA reference: 2015/005/008/051/001

Covidien llc: OxiMax™ N-65 & N-560 pulse oximeter

Oximeter 05/15

Monitors, patient

MHRA reference: 2015/005/013/071/003

Covidien: Puritan Bennett™ 980 series ventilator system

5 May 2015

Lung ventilators

Model: Puritan Bennett™ 980 Series Ventilator System

MHRA reference: 2015/002/017/081/001

Getinge Disinfection: Getinge 86-series

27 April 2015

CSSD wash/clean/drying equipment

Model: S-8666, S-8668

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

GYRUS ACMI: Gyrus ACMI Diego Elite Tubeset

29 April 2015

Surgical equipment, miscellaneous

Model: TS101DC, TS100S

MHRA reference: 2015/005/011/601/0082015

Medtronic: Micra transcatheter leadless pacemaker system

8 May 2015

Implants, active, pacemakers

Model: MC1VR01

MHRA reference: 2015/005/011/291/003

Milestone Scientific: Milestone Wand SA hand piece

8 May 2015

Anaesthetic machines and monitors

Model: STA‐5050‐305

MHRA reference: 2015/005/011/291/004

Ortho Clinical Diagnostics: ORTHO VISION™ analyser

May 2015

IVDs, blood transfusion

Model: 6904579

MHRA reference: 2015/005/007/601/001

ReliantHeart: HeartAttendant interface cable

24 April 2015

Implantable ventricular assist devices

Model: M10035

MHRA reference: 2015/004/030/291/002

ResMed: Astral 150

4 May 2015

Lung ventilators

MHRA reference: 2015/005/013/291/003

Roche Diagnostics


IVDs, clinical chemistry

Model: Drug interference in tests based on the Trinder reaction

MHRA reference: 2015/005/006/701/002

Siemens AG Medical Solutions: Siemens Multix Swing X-ray


X-ray, digital acquisition systems

MHRA reference: 2015/005/008/051/002

May 2015

IVDs, clinical chemistry

MHRA reference: 2015/005/007/601/002

Stryker Orthopaedics: Trident PSL HA solid back 50mm

11 May 2015

Joint prosthesis, hip

Model: 540-11-50E

MHRA reference: 2015/005/011/291/008

Published 15 May 2015