Device Recall KODAK DirectView DR 9000 System

  • 모델명 / 제조번호(시리얼번호)
    Service Code 1534
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
  • 제품 설명
    KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • 제조사 모회사 (2017)
  • Source
    USFDA