BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA® DIMENSIONS® 3D¿ PERFORMANCE

    MDR report key: 19553059 · Received June 17, 2024

    Report

    Report Number
    1220984-2024-00061
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 18, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    UDI-DI
    15420045517783
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6), DURING A MAMMOGRAPHY EXAMEN, WHEN TURNING INTO MLO VIEW THE C-ARM STARTED TO ROTATE 180 DEGREES BY ITSELF. A FIELD ENGINEER EXAMINED THE DEVICE AND WAS UNABLE TO REPRODUCE THE AUTO-ROTATING ON ITS OWN. THE FIELD ENGINEER REMOVED AND REPLACED GANTRY SWITCHES DUE TO THE POSSIBILITY OF STUCK SWITCHES. VERIFY THAT ALL GANTRY SWITCHES WORK CORRECTLY. THE SYSTEM PASSES ALL TESTS AND MEETS MANUFACTURER SPECIFICATIONS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071817 SELENIA® DIMENSIONS® 3D¿ PERFORMANCE MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC SDA-SYS-3000-3D 15420045517783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown