BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATOM X.CEED

    MDR report key: 23465951 · Received November 4, 2025

    Report

    Report Number
    3004977335-2025-00127
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 11, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAK
    UDI-DI
    04056869231051
    PMA / PMN Number
    K233650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHINEERS HAS COMPLETED A COMPREHENSIVE INVESTIGATION OF THE INCIDENT. THE PROVIDED LOGS AND CALIBRATION REPORTS WERE REVIEWED; HOWEVER, THE ACTUAL ROOT CAUSE COULD NOT BE DETERMINED. THE AVAILABLE EXTENSIVE SAVELOG DID NOT EXTEND TO THE DATE OF THE INCIDENT. ANALYSIS OF AUTOMATICALLY COLLECTED LOG FILES INDICATES THAT THE INTEGRATED LASER GUIDE (ILG) LASERS 2 AND 3 WERE USED TO VISUALIZE THE NEEDLE PATH AT THE REPORTED TIME OF THE INCIDENT. THERE IS NO EVIDENCE OF ANY SYSTEM MALFUNCTION. THE SUPPLIED LASER CALIBRATION REPORTS CONFIRM THAT THE LASER SYSTEM WAS FUNCTIONING CORRECTLY. NO FURTHER INVESTIGATION WAS POSSIBLE WITH THE INFORMATION AVAILABLE. NO GENERAL PRODUCT OR DESIGN ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SOMATOM X.CEED CT SYSTEM. VARIAN REPORTED THAT A PHYSICIAN WAS USING THE SIEMENS HEALTHINEERS MYNEEDLE LASER TO PLAN AND PLACE THE VARIAN IB MW (INTELLIBLATE MICROWAVE) NEEDLES. FOLLOWING THE PLACEMENT, IMAGING REVEALED THAT THE NEEDLES WERE NOT POSITIONED AS INTENDED, RESULTING IN A PARTIAL PNEUMOTHORAX OF THE PATIENT¿S RIGHT LUNG. TO ADDRESS THE COMPLICATION, THE PHYSICIAN INSERTED A 10F CHEST DRAIN, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ADVERSE HEALTH EFFECTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2778050 SOMATOM X.CEED SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK SIEMENS HEALTHINEERS AG 11330002 04056869231051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H