Field safety notices - 9 May - 13 May 2016

Summary List of field safety notices (FSNs) from medical device manufacturers from 9 - 13 May 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

Alcon Laboratories: CENTURION® FMS Pack for CENTURION® Vision System

29 April 2016

Surgical devices, non-powered

Model: Please refer to attachment 1

MHRA reference: 2016/005/005/299/004

Covidien: Bravo pH Monitoring System and Accessories

3 May 2016

Implants, active, monitors and recorder MHRA reference: 2016/005/003/701/016

Medicina: Silo Bag

05 May 2016

Ostomy and continence equipment

Model: SBXX

MHRA reference: 2016/004/028/601/013

Medtronic: Verify External Neurostimulator

May 2016

Implants, active, stimulators, neuro

Model: 3531

MHRA reference: 2016/005/006/291/001

Nipro Diagnostics: TRUEresult/STADA Blood Glucose Test Strips (FAD)

02 May 2016

IVDs, self / home testing

MHRA reference: 2016/005/004/291/006

Philips: DigitalDiagnost

19 April 2016

X Ray, digital acquisition systems

Model: 712027, 712028, 712029, 712031, 712032, 712033

MHRA reference: 2016/005/009/299/017

Philips: DuraDiagnost

25 April 2016

X Ray, general Model: 712211

MHRA reference: 2016/005/010/299/001

Philips: DuraDiagnost

25 April 2016 (FCO71200131)

X Ray, general Model: 712214

MHRA reference: 2016/005/010/299/002

Philips: MX 16-slice

April 2016

Computed tomography Model: 728131, 728132, 728135 MHRA reference: 2016/005/009/299/011

Pioneer Surgical Technology: Nunec Cervical Arthroplasty Device

05 May 2016

Spinal implants

Model: 73-MD-7

MHRA reference: 2016/005/005/601/006

Polymer Technology Systems: PTS Panels CHOL+HDL+GLU

4 February 2016

IVDs, self / home testing

MHRA reference: 2016/004/027/701/002

Schiller AG: FRED Easyport

08 March 2016

Defibrillators, non-implantable

Model: 0.900000

MHRA reference: 2016/003/030/291/001

Siemens Medical Solutions: E.CAM and Symbia family of gamma camera systems

MI001/16/S and MI002/16/S

Nuclear medicine, Gamma camera systems & accessories

Model: Various

MHRA reference: 2016/005/006/601/002

Siemens: ADVIA Centaur XPT

April 2016

IVDs, clinical chemistry

Model: 10711433

MHRA reference: 2016/005/004/601/005

Siemens: ADVIA Centaur TnI-Ultra

May 2016

IVDs, clinical chemistry

MHRA reference: 2016/005/009/601/001

Zimmer: Various knee and hip implants

04 May 2106

Central sterilisation services materials

MHRA reference: 2016/005/004/291/012

bioMérieux: Multiple product - See Table I

10 May 2016

IVDs, viral microbiology

MHRA reference: 2016/005/011/299/003 0 attachments

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