Device Recall Aquilion One CT System, TSX301A/2

  • Model / Serial
    Serial Number: 2DA0882051
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.
  • Product Description
    Whole Body X--ray Scanner || This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • Manufacturer Parent Company (2017)
  • Source
    USFDA