BEUDAMED
    FDA Enforcement Class II Ongoing

    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

    Recall: Z-1132-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1132-2023
    Event ID
    91411
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    December 21, 2022
    Classification Date
    February 13, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

    Reason

    A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

    Code Info

    UDI: 04953170202315 Serial number 2807443

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.

    Quantity

    1 unit