Field Safety Notices - 24 - 28 October 2016
Summary List of field safety notices (FSNs) from medical device manufacturers from 24 - 28 October 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
B. Braun Melsungen: UREOFIX 500 CLASSIC
24 October 2016
Urine collection devices and accessories
Model: 4417930, 4417920, 4417910
MHRA reference: 2016/010/026/291/009
Bellco: Formula, Formula Plus, Formula 2000, Formula 2000 Plus, Formula Therapy, Formula Domus
October 2016
Dialysis, haemodialysis
MHRA reference: 2016/010/021/291/017
Brainlab: BrainLAB Knee
23 September 2016
Surgical navigation system
MHRA reference: 2016/010/024/701/009
Inpeco: Aptio and FlexLab by Inpeco
25 October 2016
IVDs, clinical chemistry
MHRA reference: 2016/010/026/601/010
Intuitive Surgical: da Vinci® Xi™ Surgical System
20 October 2016
Endoscopes, rigid
Model: IS4000 Surgical System 380677 / SS4000 380652 / PS4000
MHRA reference: 2016/010/021/701/014
Medtronic: SynchroMed® II Implantable Drug Pumps
October 2106
Implants, active, infusion pumps
Model: 8637-20, 8637-40
MHRA reference: 2016/010/021/291/014
Medtronic: Charging System, RestoreSensor Charging System
FA735
Implants, active, stimulators, neuro
Model: Model 37751 Recharger included in Model 37651 Charging System for Deep Brain Stimulation (DBS), Activa RC (Model 37612)
MHRA reference: 2016/010/026/291/001
Molnlycke Healthcare: ProcedurePak trays containing Light Handle Cover (Devon™ Light Glove)
24 October 2016
Surgical devices, non-powered
MHRA reference: 2016/010/026/291/007
Nipro Corporation: SFS-5-25P
24 October 2016
Infusion & transfusion, connectors
MHRA reference: 2016/010/024/291/036
Siemens Healthcare:ADVIA Centaur Vitamin D Total
11 October 2016
IVDs, clinical chemistry
Model: 100 Test kit SMN 10699201; 500 Test kit SMN 10699533
MHRA reference: 2016/010/011/601/003
Siemens Healthcare: Combi Dockable Table Neurosurgery
10 October 2016
Magnetic resonance, equipment & accessories
Model: 10684336 / 10684337
MHRA reference: 2016/010/011/601/005
Siemens Healthcare: Chemistry Calibrator
11 October 2016
IVDs, clinical chemistry
MHRA reference: 2016/010/011/601/006
Siemens Healthcare: ADVIA 560 Hematology System
24 October 2016
IVDs, haematology
Model: SMN 11170842
MHRA reference: 2016/010/024/601/006
Signus: ROTAIO, cervical disc replacement prosthesis
07 September 2016
Spinal implants
MHRA reference: 2016/010/024/291/003
Spacelabs: Xhibit Central Station
18 October 2016
Monitors, patient
Model: 96102
MHRA reference: 2016/010/025/291/011
St. Jude Medical: Nanostim Leadless Cardiac Pacemaker (LCP) system
28 October 2016
Implants, active, pacemakers
MHRA reference: 2016/010/027/291/016
Trinity Biotech: MicroTrak® Syphilis TPHA
21 October 2016
IVDs, bacteriology
MHRA reference: 2016/010/024/291/025
Trinity Biotech: MicroTrak® RPR Syphilis
21 October 2016 - R019-16 - MicroTrak® RPR Syphilis
IVDs, bacteriology
MHRA reference: 2016/010/024/291/026
Zimmer: Java Posterior stabilization System
19 October 2016
Orthopaedic surgical instruments - Insertion/extraction tools
Model: SN2023-1-00401
MHRA reference: 2016/010/020/291/013