Field safety notices - 16 May - 20 May 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 - 20 May 2016
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
3M Deutschland: 3M ESPE Clinpro Glycine Prophy Powder with TCP
11 May 2016
Dental materials
MHRA reference: 2016/005/013/701/001
Cordis Corporation: Cordis PRECISE® PRO RX Nitinol Stent System
04 May 2016
Implants, non-active, carotid artery stents
MHRA reference: 2016/005/004/701/022
Corin: MetaFix Collarless Stem
2 May 2016
Joint prosthesis, hip
MHRA reference: 2016/005/005/601/005
Eastbourne Pharmaceuticals: Bone Wax (St Georges Hospital formula) Sterile 10G
07 March 2016
Implant materials, polymers
MHRA reference: 2016/003/009/291/002
Hoya Corporation: PENTAX Video Duodenoscope
FSCA-PMJ-16-01-1Endoscopes, Flexible
Model: ED-3490TK
MHRA reference: 2016/005/018/291/021
Immuno-Mycologics: Histoplasma Yeast CF Antigen Dilute
09 May 2016
IVDs, bacteriology
MHRA reference: 2016/005/018/071/002
Impac Medical Systems: Monaco RTP System
FCA-IMS-0013
Radiotherapy planning and verification systems
MHRA reference: 2016/005/013/701/008
Innovision: Innocor
18 May 2016
Diagnostic measurement and monitoring
Model: INN00400
MHRA reference: 2016/005/017/291/026
Intuitive Surgical: 5 - 8 mm Cannula Seal 12 mm & Stapler Cannula
Intuitive Surgical - 2955842-05/09/16-006-C
Endoscopes, rigid
MHRA reference: 2016/005/010/701/005
Maquet: MEGA/SENSATION PLUS IAB Catheters
09 May 2016.
Cardiac assist pumps
MHRA reference: 2016/005/016/291/012
Medos Medizintechnik: deltastream MDC , iLA activve & i-cor console
CAPA15-09 Heart lung machines
Model: MEMDC0001, 5000001 & 40000104
MHRA reference: 2016/005/018/291/005
Medtronic: Activa PC Neurostimulator, Activa SC Multi-program Neurostimulator, Activa PC+S, Activa RC Multi-Program Rechargable Neurostimulator, Soletra and Kinetra
May 2016
Implants, active, stimulators, neuro
Model: 37601, 37602, 37603, 37604, 37612, 7426 and 7428
MHRA reference: 2016/005/017/291/033
Medtronic: DBS Extension
May 2016
Implants, active, leads, neuro
Model: 7483, 37086, 37087
MHRA reference: 2016/005/017/291/034
Novus Scientific: TIGR Matrix Surgical Mesh
11 May 2016
Implants, non-active, abdominal & hernia mesh
Model: NSTM1015E, NSTM1520E, NSTM2030E
MHRA reference: 2016/005/017/291/011
Olerup SSP: Olerup SSP HLA typing kits
04 May 2016
IVDs, immunology
Model: A*01 Lots: 41V, 35X, 83Y A *24 Add-on Lot 32Y
MHRA reference: 2016/005/010/291/003
Redcord: Redcord Axis
14 April 2016
Therapy, traction
Model: Redcord Axis 18700/110030
MHRA reference: 2016/005/012/291/007
Siemens: Vista Enzyme 2 calibrator and Dimension Enz II cal 52903
12 May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/013/601/003
Siemens: N Latex Homocystein
May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/018/291/001
Siemens: Aptio Automation System/StreamLAB Analytical Workc
May 2016
IVDs, clinical chemistry
MHRA reference: 2016/005/019/601/008
TEOXANE: Teosyal; Teosyal PureSense
AST-1601
Implants, reconstructive, body contouring
Model: Ultimate
MHRA reference: 2016/005/013/291/018
VBM Medizintechnik: Laryngeal-Tube LTS-D Size 2 and 4
22 April 2016
Airway devices Model: LTSD
MHRA reference: 2016/005/013/291/001
Volcano Corporation: SW V 3.2.x, 3.3, 3.4 on S5/Core
06 May 2016
Ultrasound, imaging
Model: 435-0602. (01,02.05.06.07.09.10.13.15.18.19.20. 25.40)
MHRA reference: 2016/005/006/291/011
Zimmer: Anatomical Shoulder 2.0 Dome Centric
8 May 2016
Joint prosthesis, shoulder
MHRA reference: 2016/005/018/291/016