BEUDAMED
    FDA Enforcement Class III Terminated

    Neoprobe GDS Control Unit, Model Number NPCU3

    Recall: Z-0070-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0070-2021
    Event ID
    86228
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Devicor Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    September 7, 2020
    Classification Date
    October 8, 2020
    Termination Date
    May 9, 2023
    Address
    300 E Business Way Fl 5, N/A, Cincinnati, OH, 45241-2384, United States

    Description

    Neoprobe GDS Control Unit, Model Number NPCU3

    Reason

    It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.

    Code Info

    UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869

    Distribution

    The products were distributed only to China.

    Quantity

    49