BEUDAMED
    FDA Enforcement Class II Ongoing

    Colonoscope, Model Number PCF-H190DL.

    Recall: Z-1210-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1210-2024
    Event ID
    93832
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    January 11, 2024
    Classification Date
    February 29, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Colonoscope, Model Number PCF-H190DL.

    Reason

    Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

    Code Info

    Model Number: PCF-H190DL; UDI DI: 04953170363672; Serial Number: 2046148, 2046377, 2500549, 2501714, 2602501, 2602549, 2602675, 2602884, 2603086, 2605185, 2605189, 2605279, 2605338, 2605343, 2615621, 2716237, 2716306, 2716379, 2727123, 2727529, 2737897, 2738603, 2839269, 2839284, 2839580, 2840038, 2840130, 2840639, 2840669, 2840719, 2840798, 2840928, 2842302, 2942674, 2942814, 2943131, 2943193, 2943240, 2943296, 2943451, 2943708, 2943820, 2944426, 2944690, 2944765, 2944939, 2945260;

    Distribution

    US Nationwide distribution.

    Quantity

    47