BEUDAMED
    FDA Recall 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 · Initiated May 30, 2014

    Recall

    Recall Number
    Z-2137-2014
    Event Number
    68406
    Firm
    Carestream Health Inc.
    FEI Number
    1315356
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 30, 2014
    Posted
    August 1, 2014
    Terminated
    December 17, 2014
    Address
    150 Verona St, Rochester, NY, 14608-1733

    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.

    Action

    Urgent Medical Device Recall Letters (dated 5/29/2014) were sent to the consignees on 5/30/2014. Carestream Health recommends that the DR 9000 U-arm be moved before positioning the patient under the U-arm for a decubitus exam. This will remove any potential safety hazard posed to the patient as a result of any unexpected movement. For questions or concerns, please contact the Carestream Customer Care Center in the US at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the US, please call your local Service support number.

    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