BEUDAMED
    FDA Enforcement Class II Ongoing

    Visera Hysterovideoscope Olympus HYF Type V

    Recall: Z-2480-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2480-2023
    Event ID
    92783
    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 20, 2023
    Classification Date
    August 29, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Visera Hysterovideoscope Olympus HYF Type V

    Reason

    IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

    Code Info

    Model HYF-V, all serial numbers

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.

    Quantity

    363 units