BEUDAMED
    FDA Enforcement Class II Ongoing

    ZAP-X Radiosurgery System, Model: 300150

    Recall: Z-2639-2025 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-2639-2025
    Event ID
    97413
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zap Surgical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2025
    Initiation Date
    July 25, 2025
    Classification Date
    September 26, 2025
    Address
    590 Taylor Way, N/A, San Carlos, CA, 94070-6307, United States

    Description

    ZAP-X Radiosurgery System, Model: 300150

    Reason

    If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table.

    Code Info

    UDI-DI: 00860183001504, Serial Numbers: ZUC17153, ZUC20156, ZUC20157, ZUC20159, ZUC21162, ZUC21164, ZUC22166, ZUC22169, ZUC22170, ZUC22171, ZUC22173, ZUC22174, ZUC23176, ZUC23177, ZUC24179, ZUC24180, ZUC24181. Software version: TDS V1.10.1

    Distribution

    Worldwide - US Nationwide distribution in the states of FL, CO, NJ, NY and the countries of Germany, France, Spain, Poland, Republic of Korea, T¿rkiye, Paraguay.

    Quantity

    17