BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 23402395 · Received October 28, 2025

    Report

    Report Number
    3004977335-2025-00124
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 11, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED ISSUE WAS PERFORMED BY OUR EXPERTS. HOWEVER, DESPITE SEVERAL ATTEMPTS TO COLLECT THE REQUESTED INFORMATION, NO DATA OR DETAILS WERE PROVIDED FROM THE CUSTOMER SITE. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIVE ROOT CAUSE COULD BE DETERMINED. THE SYSTEM WAS RESTARTED TWICE, AND THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE, BUT IS SIMILAR TO THE ARTIS ZEE DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING SYSTEM. DURING AN INTERVENTIONAL PATIENT PROCEDURE, THE UNIT LOCKED UP AND NO RADIATION EXPOSURE WAS POSSIBLE. THIS MALFUNCTION RESULTED IN A LONG-TERM DELAY. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352212 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown