Field safety notices - 2 to 6 November 2015

List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 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

bioMerieux SA: Reference 15512: ATBTM Densitometer Control Kit, Reference 99234: Densimat

4 November 2015

Assay / reagent

MHRA reference: 2015/011/004/292/012

Fannin: Columbia Blood Agar

2 November 2015

IVDs, bacteriology

Model: W11050

MHRA reference: 2015/011/002/601/008

GE Healthcare Integrated IT Solutions: Centricity PACS-IW with Universal Viewer


Picture archiving and communication system (PACS)

Model: Centricity PACS IW with Universal Viewer 5.0 and Centricity Universal Viewer 6.0

MHRA reference: 2015/008/019/291/006

Hospira: PCA3 Drug Infusion Pump

23 October 2015

Infusion systems

Model: Plum A+

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

Lenstec: LensVisc MC, Viscoelastic 8,000 cps,Reference LT5108

16 October 2015

Implants, non-active, intraocular

MHRA reference: 2015/010/029/601/010

NxStage Medical:NxStage System One

29 October 2015

Dialysis, haemodialysis

Model: NX1000-3, NX1000-3-A

MHRA reference: 2015/011/002/292/013

Piaoan International China: Absorbent pad

2 November 2015

Basic dressings, absorbents, swabs, procedure packs

Model: 100605

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

PETER BREHM: Guiding rod

2 November 2015

Surgical instruments, implant

Model: 60900-66-2

MHRA reference: 2015/011/002/701/004

Quidel Corporation: Sofia Legionella FIA

03 November 2015

IVDs, viral microbiology

MHRA reference: 2015/011/005/292/002


UI XP044-15-S

Lithotripsy, external and internal

Model: Variostar, 01157200

MHRA reference: 2015/009/024/601/004

Siemens: Artis system equipped with a large display

19 October 2015

X ray, fluoroscopy systems

Model: various

MHRA reference: 2015/010/030/601/020

Siemens: Sysmex CA-/CS-Systems

November 2015


Model: Factor VIII chromogenic assay

MHRA reference: 2015/011/004/701/001

Thermofisher Scientific:oxoid antimicrobial susceptibility testing disc

3 November 2015

IVDs, bacteriology

Model: cefoxitin FOX30 (CT0119B)

MHRA reference: 2015/011/003/601/014

Published 9 November 2015