BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM X.CITE

    MDR report key: 25161381 · Received May 13, 2026

    Report

    Report Number
    3004977335-2026-00082
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 13, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAK
    UDI-DI
    04068151994995
    PMA / PMN Number
    K253574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHINEERS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. BASED ON THE INVESTIGATION, INCLUDING SAVELOG ANALYSIS, THE SYSTEM WAS FOUND TO BE WORKING AS SPECIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE A HANDLING ERROR, AS THE USER PRESSED (ACCIDENTALLY) THE STOP KEY ON THE CONTROL BOX, WHICH INTERRUPTED THE EXAMINATION WORKFLOW. NO GENERAL DESIGN ISSUE HAS BEEN IDENTIFIED. THEREFORE, NO REMEDIAL ACTION IS DEEMED NECESSARY AS THERE WAS NO DEVICE MALFUNCTION, AND THE SYSTEM PERFORMS IN ACCORDANCE WITH ITS SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE SOMATOM X.CITE CT SCANNER. ON (B)(6) 2026, A STROKE PATIENT WAS SCHEDULED FOR A CT SCAN; HOWEVER, THE EXAMINATION COULD NOT BE PERFORMED AS THE SYSTEM¿S PATIENT HANDLING SYSTEM (PHS) FUNCTIONALITY DID NOT WORK. AS A RESULT, THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER CT SYSTEM IN ORDER TO COMPLETE THE SCAN, LEADING TO A DELAY OF APPROXIMATELY 15 MINUTES. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT DID NOT EXPERIENCE ANY KNOWN NEGATIVE HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535607 SOMATOM X.CITE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHINEERS AG 11330001 04068151994995

    Patients

    Seq Age Sex Outcome Treatment
    1