BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 24752915 · Received April 1, 2026

    Report

    Report Number
    3004977335-2026-00043
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 2, 2026
    Report Date
    April 14, 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 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. WHILE PERFORMING AN INTERVENTIONAL PROCEDURE, DURING NORMAL X-RAY RELEASE BY PRESSING THE FOOTSWITCH, THE EXPOSURE DID NOT AUTOMATICALLY STOP ONCE THE OPERATOR RELEASED THE PEDAL. THE PROCEDURE WAS CONTINUED ON THE AFFECTED SYSTEM. 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
    609561 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown