BEUDAMED
    FDA Recall Open, Classified

    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

    Recall: Z-0181-2025 · Initiated August 21, 2024

    Recall

    Recall Number
    Z-0181-2025
    Event Number
    95421
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FET
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 21, 2024
    Posted
    October 23, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

    Reason

    It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

    Action

    An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 9/20/24 was sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above-listed device with the affected serial number. 3. Beginning October 28, 2024, please call Olympus Customer Service at 1-800-848-9024, option 3, to request a CCD Color Adjustment . Olympus will arrange for the return of your device to our Olympus Repair Center at a mutually convenient time. Olympus Repair will perform a color adjustment. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0454 c. Complete the form as instructed. Olympus requests that you report any complaints, including any imaging issues, to the Olympus Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use ofthis product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by email at [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    1407 units