BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATOM FORCE

    MDR report key: 24276585 · Received February 6, 2026

    Report

    Report Number
    3004977335-2026-00018
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 6, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAK
    UDI-DI
    04056869006956
    PMA / PMN Number
    K230421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE HARDWARE ERROR. THE REPORTED ISSUE WAS ADDRESSED BY REPLACING A POSITION SENSOR (SP WIRE SENSOR) IN THE PATIENT HANDLING SYSTEM (PHS). FOLLOWING THE REPLACEMENT, THE SYSTEM WAS VERIFIED TO BE FULLY FUNCTIONAL. AN EVALUATION OF MATERIAL CONSUMPTION RELATIVE TO THE INSTALLED BASE, AS MONITORED THROUGH THE CAPA PROCESS, DEMONSTRATED THAT USAGE LEVELS REMAIN WITHIN ESTABLISHED SPECIFICATIONS. NO SYSTEMIC PRODUCT ISSUE OR DESIGN RELATED DEFICIENCY COULD BE IDENTIFIED. THEREFORE, NO ADDITIONAL INVESTIGATION IS CONSIDERED NECESSARY. A SAFETY ASSESSMENT WAS PERFORMED, AND NO INCREASED RISK TO PATIENTS OR USERS WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SOMATOM FORCE CT SYSTEM. BASED ON THE INFORMATION AVAILABLE, A PERFUSION SCAN WAS ABORTED AND SUBSEQUENTLY HAD TO BE REPEATED. AS A RESULT, THE ACUTE STROKE PATIENT REQUIRED A SECOND SCAN AND A SECOND ADMINISTRATION OF CONTRAST MEDIUM. THE SCAN ABORT CAUSED A DELAY OF APPROXIMATELY 15 MINUTES IN ESTABLISHING THE DIAGNOSIS. NO INJURIES OR ADVERSE HEALTH EFFECTS HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344347 SOMATOM FORCE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHINEERS AG 10742326 04056869006956

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male