BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

    Recall: Z-1694-2026 · Initiated February 27, 2026

    Recall

    Recall Number
    Z-1694-2026
    Event Number
    98422
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 27, 2026
    Posted
    March 30, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

    Reason

    Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

    Action

    On February 27, 2026 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any of the affected devices listed in the attachment. 2. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 3. Olympus representatives will begin contacting customers to coordinate the service of affected unit(s). In the meantime, you may continue using your SOLTIVE Laser until the service is completed. Olympus will replace the 24V power supply module at no charge to you. Note: Any issues beyond the replacement of the 24V module in this corrective action will follow the standard SOLTIVE Laser repair process and your service contract, if applicable. 4. If you have further distributed the affected products, please forward this notice to other users who may be impacted.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Chile, Europe, Singapore, Australia, and Hong Kong.

    Quantity

    408 units