BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS PHENO

    MDR report key: 22636516 · Received July 28, 2025

    Report

    Report Number
    3004977335-2025-00088
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 28, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869046877
    PMA / PMN Number
    K241572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS PERFORMED BY OUR EXPERTS. DETAILED LOG-FILE INVESTIGATION SHOWED THAT DURING THE SHUTDOWN PROCEDURE, THE IVS AND IMAGE ACQUISITION SYSTEM (IAS) CRASHED ABRUPTLY WITHOUT ANY FURTHER LOGGING ACTIVITY HINTING TOWARD POSSIBLE HW FAILURE. THE REPORTED ISSUE WAS REPRODUCED, AND IT WAS IDENTIFIED THAT THE ABRUPT SYSTEM SHUTDOWN ISSUE OBSERVED AFTER UPGRADING FROM THE SW VERSION VE10 TO VE30 IS CAUSED BY A FIRMWARE DEFECT IN THE CONTROL INTERFACE BOX (CIB), SPECIFICALLY IN THE LAB POWER INTERFACE (LPI) FIRMWARE VERSION. 01. THE ISSUE IS CAUSED BY THE DELAY COUNTER VARIABLE NOT BEING REINITIALIZED AFTER THE FIRST SHUTDOWN. AS A RESULT, SUBSEQUENT SHUTDOWNS COULD BYPASS THE INTENDED DELAY, LEADING TO AN ABRUPT POWER-OFF APPROXIMATELY 4 SECONDS AFTER THE SHUTDOWN COMMAND, RESULTING IN THE REPORTED ISSUE. ADDITIONALLY, IT IS NOTED THAT THE ISSUE OCCURS DURING A SECOND SHUTDOWN ONLY AFTER A COMPLETE POWER CYCLE OF THE CONTROL INTERFACE BOX (CIB) DUE TO A POWER CUT/FAILURE. AS A RESULT, THE ROBOT CANNOT BE MOVED IMMEDIATELY AFTER BOOTING DUE TO NO COMMUNICATION BETWEEN THE ROBOT AND THE IVS. IN THE REPORTED CASE, NORMAL SYSTEM FUNCTIONALITY WAS RESTORED BY A SERVICE INTERVENTION. THIS ISSUE IS DETERMINED TO BE SPORADIC BUT SYSTEMATIC FOR THE MENTIONED CONFIGURATION WITH THE SEQUENCE OF EVENTS MENTIONED ABOVE. SINCE ONLY SYSTEMS THAT HAVE CIBS WITH FIRMWARE VERSION 01 ARE AFFECTED, THE VE10 TO VE30 UPGRADE HAS BEEN ADAPTED, THUS PREVENTING FURTHER DISTRIBUTION OF THE PROBLEM TO OTHER SYSTEMS. AN UPDATE INSTRUCTION AX032/25/S WILL BE RELEASED BY SIEMENS FOR THE AFFECTED SYSTEMS TO ELIMINATE THE ISSUE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS PHENO SYSTEM. THE MACHINE WAS POWERED UP; HOWEVER, SYSTEM MOVEMENTS WERE BLOCKED. TO RESOLVE THE PROBLEM, FILES WERE RELOADED ON THE ROBOT, AND THE SYSTEM WAS RESTARTED AS PART OF SERVICE ACTIVITY. NO HEALTH CONSEQUENCES WERE REPORTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508137 ARTIS PHENO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10849000 04056869046877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown