BEUDAMED
    FDA Enforcement Class II Ongoing

    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

    Recall: Z-2467-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2467-2023
    Event ID
    92703
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 27, 2023
    Classification Date
    August 28, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

    Reason

    Recent reports of patient infection.

    Code Info

    Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.

    Distribution

    US Nationwide distribution.

    Quantity

    6,426 units