BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

    Recall: Z-2490-2023 · Reported September 6, 2023

    Enforcement

    Recall Number
    Z-2490-2023
    Event ID
    92779
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2023
    Initiation Date
    July 27, 2023
    Classification Date
    August 31, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.

    Reason

    Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

    Code Info

    UDI-DI: 04953170308185, 04953170288968, 04953170308161, 04953170339264, 04953170308277, 04953170339394, 04953170308178, 04953170288876, 04953170308123, 04953170339196, 04953170062988, 04953170339974, 04953170063008, 04953170339998, & 04953170340147; All Serial Numbers.

    Distribution

    US Nationwide distribution.

    Quantity

    1715 units