BEUDAMED
    FDA Recall Open, Classified

    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

    Recall: Z-2554-2026 · Initiated May 5, 2026

    Recall

    Recall Number
    Z-2554-2026
    Event Number
    99064
    Firm
    IPG Medical Corporation
    FEI Number
    3020221089
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 5, 2026
    Posted
    June 24, 2026
    Address
    225 Cedar Hill St, Marlborough, MA, 01752-5900

    Description

    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

    Reason

    Software anomaly that causes a false display of error code 5018.

    Action

    An URGENT MEDICAL DEVICE RECALL notice dated 05/05/2026 was emailed to IPG Medical's consignee notifying them of this recall correction to address Error 5018 and Error 5007/5023 displayed on monitors with software version 2.2. The notification provides instructions to consignees to work around the error messages until a software upgrade is deployed at a later date. The notification instructs consignees that their staff may correct units onsite via software upgrade or units may be returned to IPG Medical for a factory correction when the update is available. A corrected IFU will be provided to all customers. Questions can be directed via phone to 774-633-5903 or [email protected].

    Distribution

    US Nationwide distribution in the state of MA.

    Quantity

    198 units