Field safety notices - 8 to 12 June 2015

List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 June 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


28 May 2015

Endoscopes, televisual systems

MHRA reference: 2015/006/002/291/012

Biomet Orthopaedics: A.L.P.S. cortical locking screw 3.5mm x 60mm

9 June 2015

Osteosynthesis, bone screws

MHRA reference: 2015/006/009/131/002

Fresenius Medical Care: KGaA: FX CorDiax 40, 50, 120 and FX CorDiax HDF600

2 June 2015

Dialysis, haemodialysis

Model: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00001593, F00001594, F00001595

MHRA reference: 2015/003/010/081/017

Gainsborough Bathrooms: Gainsborough Bath

June 2015

Bath and aids

Model: Kent

MHRA reference: 2015/006/010/601/002

GE Medical Systems: Innova, Optima and Discovery interventional system

9 June 2015

X ray, fluoroscopy systems

MHRA reference: 2015/006/010/291/003

Philips Medical Systems: Q-Station

11 May 2015

Picture archiving and communication system (PACS)

MHRA reference: 2015/006/005/291/013

RaySearch Laboratories

29 May 2015

Radiotherapy planning and verification

Model: RayStation

MHRA reference: 2015/006/008/701/007

Roche Diabetes Care


Infusion systems

Model: Accu-Chek® Insight

MHRA reference: 2015/006/011/701/006

Roche Diagnostics

3 June 2015

IVDs, clinical chemistry

Model: various models

MHRA reference: 2015/006/009/701/002

Smith & Nephew Orthopaedics: Birmingham Hip™ Resurfacing (BHR) system

3 June 2015

Joint prosthesis, hip

MHRA reference: 2015/006/005/291/012

Stryker: X3 Triathlon Insert CR#2 9MM

29 May 2015

Joint prosthesis, knee

Model: 5530G209

MHRA reference: 2015/006/002/291/002

Unisurge International Limited: Unisurge oral swab applicators

5 June 2015

Basic dressings, absorbents, swabs, procedure packs

Model: F824330

MHRA reference: 2015/006/005/601/020

Published 12 June 2015