Blue Goat Cyber logoBlue Goat CyberSMMedical Device Cybersecurity
    K
    Goat Feed · Software Quality

    FDA Recall: IPG Medical Corporation, Powered Laser Surgical Instrument

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

    Back to the daily feed
    Software Quality
    info

    Recalling firm: IPG Medical Corporation

    Device class: 2

    Device name: Powered Laser Surgical Instrument

    Event initiated: 2026-05-05

    FDA posted: 2026-06-24

    Recall ID: Z-2554-2026

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

    Reason for recall

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

    Citations
    #recall#gray-zone
    Need help acting on this?

    Talk to Blue Goat Cyber

    Penetration testing, SBOM, threat modeling, and 524B submission support for MedTech.