BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAP-X RADIOSURGICAL SYSTEM

    MDR report key: 22551682 · Received July 20, 2025

    Report

    Report Number
    3012039133-2025-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ZAP SURGICAL SYSTEMS INC.
    Product Code
    IYE
    PMA / PMN Number
    K211663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZAP'S INITIAL INVESTIGATION, DETERMINED THAT THE SYSTEM'S AUTOMATED RETREAT LOGIC, DESIGNED TO REVERSE COURSE AFTER A PROXIMITY WARNING, DOES NOT ALWAYS EFFECTIVELY MITIGATE COLLISION RISK UNDER A NARROW SET OF CIRCUMSTANCES AFTER THE GANTRY HAS TRAVELED MORE THAN 180 DEGREES. THIS ISSUE IS COMPOUNDED BY A SEPARATE SOFTWARE DEFECT THAT MAKES THE GANTRY MORE PRONE TO MOVES GREATER THAN 180 DEGREES.

    Description of Event or Problem · 0

    ZAP BECAME AWARE OF A SYSTEM MALFUNCTION WHERE DURING A PATIENT TREATMENT THERE WAS A COLLISION BETWEEN THE ZAP-X COLLIMATOR WHEEL AND THE MASK CLIPS WHICH WAS ATTACHED TO THE PATIENT TABLE. NO PATIENT INJURY OCCURRED. ZAP IS REPORTING THIS EVENT UNDER AN ABUNDANCE OF CAUTION. TO DATE ZAP IS NOT AWARE OF ANY INSTANCES OF A COLLISION BETWEEN THE SYSTEM AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783961 ZAP-X RADIOSURGICAL SYSTEM MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM IYE ZAP SURGICAL SYSTEMS INC. ZAP-X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown