BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2137-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2137-2014
    Event ID
    68406
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carestream Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    May 30, 2014
    Classification Date
    August 1, 2014
    Termination Date
    December 17, 2014
    Address
    150 Verona St, N/A, Rochester, NY, 14608-1733, United States

    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.

    Reason

    A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.

    Code Info

    Service Code 1534

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.

    Quantity

    Domestic: 100 units; Foreign: 46 units