BEUDAMED
    FDA Enforcement Class II Terminated

    EVIS EXERA III Bronchovideoscope

    Recall: Z-1559-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1559-2022
    Event ID
    90664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aizu Olympus Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 31, 2022
    Initiation Date
    July 20, 2022
    Classification Date
    August 19, 2022
    Termination Date
    January 22, 2025
    Address
    1 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan

    Description

    EVIS EXERA III Bronchovideoscope

    Reason

    The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

    Code Info

    UDI-DI: 04953170342134; Serial No. 2911858; Model No. BF-XP190.

    Distribution

    US Nationwide distribution in the states of FL, IL, NC, PA & TX.