BEUDAMED
    FDA Recall Open, Classified

    Visera Hysterovideoscope Olympus HYF Type V

    Recall: Z-2480-2023 · Initiated July 20, 2023

    Recall

    Recall Number
    Z-2480-2023
    Event Number
    92783
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    HIH
    Status
    Open, Classified
    Root Cause
    Reprocessing Controls
    Initiated
    July 20, 2023
    Posted
    August 29, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Visera Hysterovideoscope Olympus HYF Type V

    Reason

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

    Action

    A customer letter was issued on July 20, 2023. Customers were advised that the Instructions for use were updated. Customers are asked to complete a response form of acknowledgement and submit to Sedgwick at [email protected] or Fax 866-557-1242.

    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