BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

    Recall: Z-1921-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1921-2025
    Event ID
    96723
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 18, 2025
    Initiation Date
    May 6, 2025
    Classification Date
    June 6, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

    Reason

    Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

    Code Info

    All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);

    Distribution

    Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

    Quantity

    1549 units (1025 US, 524 OUS)