BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 24116515 · Received January 20, 2026

    Report

    Report Number
    3004977335-2026-00010
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 12, 2026
    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 EVENT WAS COMPLETED BY OUR EXPERTS. INITIALLY HOSPITAL¿S BIOMED DEPARTMENT MADE AN ATTEMPT TO RESOLVE THE ISSUE BUT WAS UNSUCCESSFUL AND HAD TO CONTACT SIEMENS LOCAL SERVICE FOR SUPPORT. UNDER REMOTE GUIDANCE FROM THE SIEMENS SERVICE ENGINEER, A POWER REBOOT OF THE SYSTEM WAS PERFORMED, AFTER WHICH THE SYSTEM RETURNED TO NORMAL OPERATION A MORE DETAILED AND VERIFIABLE ANALYSIS OF THE REPORTED ISSUE WAS NOT POSSIBLE DUE TO THE ABSENCE OF LOG FILES AND NO ONSITE INTERVENTION BY SIEMENS SERVICE. ADDITIONALLY, NO SPARE PARTS WERE REPLACED DURING THE RESOLUTION PROCESS. BASED ON EXPERT ASSESSMENT AND CONSIDERING THAT NO FURTHER ISSUES WERE REPORTED FOLLOWING THE SYSTEM POWER REBOOT, THE EXACT ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED RETROSPECTIVELY. THE OCCURRENCE RATE OF THE AFOREMENTIONED ERROR PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH LEADS TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.

    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 THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL 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 EMERGENCY PATIENT PROCEDURE, NO X-RAY EXPOSURE WAS POSSIBLE, WHICH LED TO A DELAY OF THE PROCEDURE. 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
    178550 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown