BEUDAMED
    FDA Enforcement Class II 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 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0644-2016
    Event ID
    72915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CompView Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 20, 2016
    Initiation Date
    December 4, 2015
    Classification Date
    January 13, 2016
    Termination Date
    March 31, 2016
    Address
    2818 E 2nd St, Suite 200, Vancouver, WA, 98661-7778, United States

    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.

    Code Info

    Lot# T9993-02-01 /15924CARTXXTNNA / DX00357 Lot# T9993-02-02 / 15924CARTXXAZPH / DX00358 Lot# U0328-02-02 / 15A01CARTXXCOEN /DX00360 Lot# U0328-02-01 / 15A26CARTXXCAK1 / DX00359 Lot# U0718-02-01 / 15A26CARTXXCAK2 / DX00361 Lot# U0718-02-02 / 15A26CARTXXCAK3 / DX00362 Lot# U1033-02-01 / 15A19CARTXXOHCA /DX00363 Lot# U1033-02-02 / 15A26CARTXXCASJ / DX00364 Lot# U1126-02-01 / 15A26CARTXXCAK41 /DX00365 Lot# U1126-02-02 / 15806CARTXXGAAT / DX00366

    Distribution

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

    Quantity

    10 units