Device Recall KODAK DirectView DR 9000 System

  • Model / Serial
    Service Code 1534
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Carestream Health Inc., 150 Verona St, Rochester NY 14608-1733
  • Manufacturer Parent Company (2017)
  • Source
    USFDA