BEUDAMED
    FDA Enforcement Class II Ongoing

    Soltive Premium SuperPulsed Laser System, Model TFL-PLS

    Recall: Z-2504-2024 · Reported August 14, 2024

    Enforcement

    Recall Number
    Z-2504-2024
    Event ID
    94964
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2024
    Initiation Date
    May 31, 2024
    Classification Date
    August 5, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Soltive Premium SuperPulsed Laser System, Model TFL-PLS

    Reason

    Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

    Code Info

    Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.

    Distribution

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

    Quantity

    1,585 Units