Device Recall Aquillion One TSX301A/2D

  • Modelo / Serial
    Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution to CA, MA, MD
  • Descripción del producto
    Cardiac Function Analysis Software || Product Data No. MPDCT0301EAD || CSCF-003A || The software is applicable to the following CT systems: || Aquilion ONE TSX-301A/2D || X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA