BEUDAMED
    FDA Enforcement Class I Ongoing

    Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

    Recall: Z-2012-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2012-2023
    Event ID
    92362
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    June 8, 2023
    Classification Date
    July 17, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

    Reason

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

    Code Info

    All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998

    Distribution

    US Nationwide Distribution.

    Quantity

    4 units