BEUDAMED
    FDA Enforcement Class I Ongoing

    Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

    Recall: Z-2016-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2016-2023
    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 EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

    Reason

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

    Code Info

    All serial numbers BF-P180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 UDI: 04953170339288 BF-Q180** EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 UDI: 04953170339301 BF-Q180-AC* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC UDI: 04953170340086 BF-1T180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 UDI: 04953170339325 BF-1TQ180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 UDI: 04953170339349

    Distribution

    US Nationwide Distribution.

    Quantity

    17,609 units