BEUDAMED
    FDA Adverse Event Summary report: N

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    MDR report key: 1315872 · Received February 18, 2009

    Report

    Report Number
    2950679-2009-00001
    Date Received
    February 18, 2009
    Date of Event
    January 13, 2009
    Report Date
    February 11, 2009
    Manufacturer
    ACCURAY, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K011024
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCURAY IS INVESTIGATING THIS ISSUE WITH THE USER FACILITY AND WILL PROVIDE RESULTS WHEN AVAILABLE.

    Description of Event or Problem · 1

    IN 2009, THE FACILITY'S PHYSICS DEPARTMENT INFORMED ACCURAY FIELD SERVICE ENGINEERING THAT THE TOTAL TARGETING ERROR TEST RESULTS DETERMINED BY MONTHLY END TO END TESTING CONDUCTED IN 2009, WERE OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE SYSTEM MUJ ACCURAY, INC. CYBERKNIFE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA