Device Recall TSX301A/2 Aquilion One CT System

  • 모델명 / 제조번호(시리얼번호)
    Item number TSX-301 A/2D Serial Numbers: 2DA0792004, 2DA07X2005, 2DA07Y2010, 2DA0792002, 2DA07X2008, 2DA0842023.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: MA, MD, and NV.
  • 제품 설명
    TSX-301A/2 Aquilion One CT System. || The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. || This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capable of proving data for dynamic and perfusion studies of organs and extremities.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92780-7047
  • 제조사 모회사 (2017)
  • Source
    USFDA