BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS DRF MAX

    MDR report key: 24616109 · Received March 17, 2026

    Report

    Report Number
    3004977335-2026-00035
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 17, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869009155
    PMA / PMN Number
    K173639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): CURRENTLY NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE, WHICH REQUIRES IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL REPORTABLE INFORMATION AND/OR INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS NOTIFIED OF A PROBLEM INVOLVING THE LUMINOS DRF MAX SYSTEM. IT WAS STATED THAT DURING AN EXAMINATION, THE PATIENT TABLE TILTED COUNTERCLOCKWISE WITHOUT REQUEST. THE USER WAS ABLE TO STOP THE MOVEMENT. THERE WERE NO INJURIES COMMUNICATED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685011 LUMINOS DRF MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10762471 04056869009155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown