Field safety Notice - 8 August to 12 August
Summary List of field safety notices (FSNs) from medical device manufacturers from 8 - 12 August 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
View the latest FSNs
Bayer: Medrad® Stellant with Certegra Workstation
August 2016
Media Injectors
Model: Certegra® Workstation used in conjunction with Medrad® Stellant® CT Injection System
MHRA reference: 2016/008/008/701/009
Beckman Coulter: UniCel DxH Slidemaker Stainer (SMS)
8 August 2016
IVDs, haematology
MHRA reference: 2016/008/008/601/007
Boston Scientific: Uphold™ LITE Vaginal Support System with Capio™ SLIM, PinnacleTM LITE Pelvic Floor Repair Kit, Posterior with CapioTM SLIM, Upsylon™ Y Mesh Kit with Colpassist™ Vaginal Positioning Device
06 June 2016
Implants, non-active, implantable incontinence and prolapse devices
MHRA reference: 2016/006/002/291/014
Boston Scientific: Advantage™ and Advantage Fit™ System, Transvaginal Sling, Lynx™ System, Suprapubic Sling Obtryx™ System, (Curved or Halo), Transobturator Sling, Obtryx™ II System with PrecisionBlue™ Design, (Curved or Halo), Transobturator Sling, Solyx™ SIS System, Single Incision Sling
06 June 2016 - 91130383-FA - Mesh Slings
Implants, non-active, implantable incontinence and prolapse devices
MHRA reference: 2016/008/001/291/003
Boston Scientific: • Xenform™ Soft Tissue Repair Matrix
06 June 2016 - 91130383-FA - Xenform
Implants, non-active, implantable incontinence and prolapse devices
Model: M0068302410, M0068302430, M0068302450, M0068302470
MHRA reference: 2016/008/001/291/002
09 August 2016
IVDs, viral microbiology
MHRA reference: 2016/008/010/299/004
Elekta
200 01 103 061
Radiotherapy
Model: Machine numbers 105345 to 151764
MHRA reference: 2016/008/004/701/012
LeMaitre Vascular: Hydro LeMaitre Valvulotome
09 August 2016
Surgical instruments, non-articulated cutting
Model: 1009-00, 1009-00J
MHRA reference: 2016/008/009/701/012
MedXpert: Strasbourg Thorax Osteosyntheses System
02 November 2015
Osteosynthesis, bone plates
MHRA reference: 2016/007/026/291/002
Mediplus: Chalfont connector
10 August 2016
Infusion & transfusion, administration sets
MHRA reference: 2016/008/011/701/016
Nutricia: Flocare Infinity II Enteral feeding pump
11August 2016
Feeding systems and tubes
Model: 35676 / 35679 / 35682 / 35685 / 35677 / 35680 / 35683
MHRA reference: 2016/008/010/299/006
ResMed: Astral 150
12 August 2016
Lung ventilators
MHRA reference: 2016/008/002/291/002
Siemens: syngo RT Therapist TM
TH004/16/S
Radiotherapy
Model: syngo RT Therapist 008162815
MHRA reference: 2016/008/005/601/014
Siemens: ADVIA Centaur Systems Calibrator U (Myoglobin) 41733
10 August 2016
IVDs, clinical chemistry
MHRA reference: 2016/008/010/601/005
Terumo:MISAGO® Self-Expanding Stent System
FSCA 1602
Implants, non-active, peripheral vascular stents
Model: Product codes start with SX-V
MHRA reference: 2016/008/004/701/010
bioMérieux: VIDAS TOXO Competition
04 August 2016
IVDs, viral microbiology
MHRA reference: 2016/008/005/299/004
bioMérieux: BK Virus R-gene® Real-time Detection and Quantification Kit
09 August 2016
IVDs, viral microbiology
MHRA reference: 2016/008/010/299/004