BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

    Recall: Z-1715-2025 · Reported May 7, 2025

    Enforcement

    Recall Number
    Z-1715-2025
    Event ID
    96566
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2025
    Initiation Date
    April 4, 2025
    Classification Date
    May 1, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

    Reason

    Preset treatment parameters are not consistently being used in accordance with the IFU.

    Code Info

    SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-PLS - 00821925044111 All units included Powered Laser Surgical Instrument - Laser module component information Name: TFL Premium Laser Unit, TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586; TFL-CSLU - 00821925044593

    Distribution

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

    Quantity

    189