BEUDAMED
    FDA Recall Terminated

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    Recall: Z-2497-2021 · Initiated August 17, 2021

    Recall

    Recall Number
    Z-2497-2021
    Event Number
    88560
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    EOQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 17, 2021
    Terminated
    January 12, 2024
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    Reason

    A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

    Action

    On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact [email protected] for additional information.

    Distribution

    US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

    Quantity

    27 globally (21 US)