BEUDAMED
    FDA Enforcement Class I Ongoing

    BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

    Recall: Z-0189-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0189-2024
    Event ID
    93052
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    October 12, 2023
    Classification Date
    November 9, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160

    Reason

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

    Code Info

    Model BF-1T150 UDI-DI: 4953170308185; Model BF-1T60 UDI-DI: 4953170339264; Model BF-P150 UDI-DI: N/A; Model BF-P60 UDI-DI: 4953170339196; Model BF-XT160 UDI-DI: N/A

    Distribution

    US Nationwide distribution

    Quantity

    15942 devices