Devices

Device Recall TomoTherapy HiArt System, ver. 4.0.0, 4.0.1, 4.0.2.

  • Modelo / Serial
    Serial #'s:  110019, 110083, 110169, 110284, 110305, 110312, 110034, 110091, 110174, 110285, 110306, 110314, 110037, 110092, 110278, 110288, 110308, 110316, 110056, 110150, 110281, 110293, 110309, 110318, 110065, 110159, 110283, 110300, 110311
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
  • Descripción del producto
    TomoTherapy Hi-Art System¿, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System¿ is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
  • Manufacturer
    TomoTherapy Incorporated
  • 1 Event

Fabricante

TomoTherapy Incorporated
  • Dirección del fabricante
    TomoTherapy Incorporated, 1240 Deming Way, Madison WI 53717
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    USFDA