BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS AGILE MAX

    MDR report key: 21503082 · Received March 3, 2025

    Report

    Report Number
    3004977335-2025-00031
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869009162
    Removal / Correction Number
    RES# 94948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS PRELIMINARY ANALYSIS: THE ROOT CAUSE FOR THE ISSUE HAS NOT YET BEEN DETERMINED. THE INVESTIGATION IS ONGOING. THE ROOT CAUSE WILL BE COMMUNICATED VIA RES# 94948. CORRECTIVE/PREVENTATIVE ACTIONS FOR THIS SYSTEM WERE COMPLETED VIA UI XP018/24/S. SIEMENS WILL NOT SUBMIT A SUPPLEMENTAL REPORT BECAUSE THE ISSUE, AND THE COMPLAINT SYSTEM STATUS, WILL BE ADDRESSED IN RES# 94948 REPORTS TO THE FDA.

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: D3: THE MANUFACTURER'S NAME WAS CORRECTED TO SIEMENS HEALTHINEERS AG.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM RELATED TO SIEMENS RECALL XP017/24/S UI XP018/24/S, RES #94948. IT WAS DISCOVERED THAT AT THE FIXATION OF THE MONITOR CEILING SUSPENSION THE SECURING SEGMENT WAS NOT INSTALLED CORRECTLY. THE MONITOR SUPPORT ARM REMAINED ATTACHED TO THE CEILING AND NO INJURY OCCURRED DUE TO THIS ISSUE. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, IF THE SUPPORT ARM HAD BEEN USED FURTHER WITHOUT NOTICING THE ISSUE, A SERIOUS INJURY COULD BE SUSTAINED FROM FALLING EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329638 LUMINOS AGILE MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10762472 04056869009162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown