BEUDAMED
    FDA Enforcement Class II Ongoing

    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

    Recall: Z-1275-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1275-2022
    Event ID
    90232
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 29, 2022
    Initiation Date
    April 22, 2022
    Classification Date
    June 21, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

    Reason

    Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

    Code Info

    UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545

    Distribution

    US Nationwide distribution in the states of AL, FL, NC, NY.

    Quantity

    8 units