BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q ZEEGO

    MDR report key: 23166226 · Received September 29, 2025

    Report

    Report Number
    3004977335-2025-00116
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 10, 2025
    Report Date
    December 22, 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 DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO BRAND NAME OF THE USA CLEARED DEVICE WITH THE FOLLOWING 510(K) NUMBER - K181407. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE 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 Q ZEEGO SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO SYSTEM MOVEMENTS WERE AVAILABLE. THE PATIENT HAD TO BE MOVED TO COMPLETE THE PROCEDURE ON THE AN ALTERNATE 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
    1217855 ARTIS Q ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10848460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown