Field safety notices - 2 to 6 November 2015
List of field safety notices (FSNs) from medical device manufacturers from 2 to 6 November 2015.
Overview
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
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
FMI85404-A
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
Siemens: MODULARIS
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
Coagulation
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