Field safety notices - 30 to 03 April 2015
List of field safety notices (FSNs) from medical device manufacturers from 30 to 3 April 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
View the latest FSNs
AcuFocus: KAMRA corneal inlay
March 2015
Device description: implants, non active, intraocular
Model: ACI 7000
MHRA reference: 2015/003/027/701/001
ArcRoyal: Terumo two part syringe
20 March 2015
Device description: injection devices
MHRA reference: 2015/003/031/701/003
BTE Technologies: Primus
19 March 2015
Device description: diagnostic measurement and monitoring
Model: PrimusRS (PRRS)
MHRA reference: 2015/003/027/701/006
GE Healthcare: Millennium VG, Discovery VH, VariCam
FMI 40865
Device description: gamma camera
Model: Millennium VG, Discovery VH, VariCam (all configurations)
MHRA reference: 2015/003/026/071/004
Johnson & Johnson Medical: Omrix pressure regulators
13 March 2015
Device description: surgical devices, non-powered
MHRA reference: 2015/003/026/071/009
Life Technologies Corporation: A*02 SSP UniTray, Allset Gold Plus SSP and A High Res SSP UniTray, Allset Gold Plus SSP
16 March 2015
Device description: IVDs, immunology
MHRA reference: 2015/003/031/601/008
Philips Healthcare : ADAC Vertex Plus, CARDIO and Solus ADAC V60 ADAC C60
12 February 2015
Device description: nuclear medicine, gamma camera systems & accessories
Model: Manual Collimator Exchange system in use with an ADAC VERTEX Plus, CARDIO, SOLUS or VERTEX V60 imaging system - 88297: ADAC Vertex Plus, CARDIO and Solus 882380: ADAC V60 882040: ADAC C60
MHRA reference: 2015/004/001/071/007
Prism Medical: Freeway M150
16 March 2015
Device description: hoists and slings
MHRA reference: 2015/002/025/081/024
Siemens Healthcare Diagnostics: ADVIA chemistry lipase reagent
March 2015
Device description: IVDs, clinical chemistry
MHRA reference: 2015/003/027/601/003
Siemens Healthcare Diagnostics: ADVIA Centaur XPT
March 2015 (CSW 15-02)
Device description: IVDs, clinical chemistry
MHRA reference: 2015/004/001/601/002
Siemens: Artis Q, Artis Q.zen
06 March 2015
Device description: X-ray, fluoroscopy systems
MHRA reference: 2015/003/026/601/003
Siemens: AXIOM Aristos FX
UI XP090/14/S and UI XP091/14/S
Device description: X-ray, general
Model: 7414803
MHRA reference: 2015/003/026/601/012.
Terumo: Terumo Radifocus Optitorque Catheter
04 /2015
Device description: vascular cannula and catheters
Product code: RH-5TIG110M
MHRA reference: 2015/004/001/071/010
Thermo Fisher: oxoid antimicrobial testing disc CN10
27 March 2015
Device description: IVDs, bacteriology
Model: CT0024B CN10 Gentamicin
MHRA reference: 2015/003/030/601/003
Thermo Fisher Scientific: oxoid modified tryptone soya broth
31 March 2015
Device description: IVDs, bacteriology
Model: CM0989B
MHRA reference: 2015/003/031/601/007