BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-1275-2022
    Event Number
    90232
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDS
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    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

    Action

    Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide for a service loaner in an effort to not disrupt patient care. Please do not hesitate to contact @ 647-999-3203 or at [email protected] for any additional information or support concerning this matter.

    Distribution

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

    Quantity

    8 units