BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 22809666 · Received August 14, 2025

    Report

    Report Number
    3004977335-2025-00099
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 26, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    PMA / PMN Number
    K181407
    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 WAS COMPLETED BY OUR EXPERTS BY ANALYZING COMPLAINT DESCRIPTION, SERVICE REPORTS, SYSTEM HISTORY, AND SYSTEM LOG FILES. THE UNIT WAS INSPECTED BY SIEMENS LOCAL SERVICE. THE INSPECTION REVEALED A LOOSENED TUBE COVER THAT WAS MECHANICALLY OBSTRUCTING THE COLLIMATOR, THEREBY PREVENTING ITS ROTATION. UPON REMOVAL OF THE COVER, THE COLLIMATOR¿S FUNCTIONALITY WAS RESTORED. THE SERVICE ENGINEER RE-INSTALLED THE TUBE COVER IN THE CORRECT POSITION, AFTER WHICH THE SYSTEM RESUMED NORMAL OPERATION. THE NON-CONFORMITY WAS ATTRIBUTED TO THE LOOSE TUBE COVER; HOWEVER, THE UNDERLYING CAUSE OF THE LOOSENING COULD NOT BE RETROSPECTIVELY ESTABLISHED. 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. 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

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING. PRIOR TO AN EMERGENCY PATIENT PROCEDURE, THE USER DISCOVERED THAT NO 3D MODE WAS AVAILABLE. THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL FOR FURTHER MEDICAL TREATMENT. 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
    1628107 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown