BEUDAMED
    FDA Recall Terminated

    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.

    Recall: Z-0644-2016 · Initiated December 4, 2015

    Recall

    Recall Number
    Z-0644-2016
    Event Number
    72915
    Firm
    CompView Medical, LLC
    FEI Number
    3006293618
    Product Code
    LMD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 4, 2015
    Posted
    January 13, 2016
    Terminated
    March 31, 2016
    Address
    2818 E 2nd St, Suite 200, Vancouver, WA, 98661-7778

    Description

    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.

    Reason

    The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach.

    Action

    The firm began inspecting devices between 12/4/15 and 12/16/15, and sent the Nucart Product Investigation letter to consignees between 12/11/15 and 12/15/15. Consignees with questions can call the firm at 503-601-5603.

    Distribution

    US nationwide distribution including AZ, CA, CO, GA, OH, and TN.

    Quantity

    10 units