BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

    MDR report key: 23247124 · Received October 8, 2025

    Report

    Report Number
    3005496266-2025-00070
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 8, 2025
    Manufacturer
    HOLOGIC INC
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE USER SITE THAT DURING A SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM PATIENT EXAM ON (B)(6) 2025, THE C-ARM OF THE DEVICE WAS SHAKING DURING THE TOMO SWEEP. NO INJURIES OR PATIENT OR USER IMPACT WAS REPORTED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE DEVICE. THE FSE CONFIRMED THAT ROTATIONAL GEAR OF THE C-ARM HAD LOOSE BOLTS. THE FSE WAS ABLE TO TIGHTEN AND SECURE THE HARDWARE. THE FSE COMPLETED CALIBRATIONS PER HOLOGIC RECOMMENDATIONS AND CONFIRMED THAT THE TOMO SWEEP SHAKING NO LONGER PERSISTED. THE SYSTEM WAS CONFIRMED BY THE FSE TO BE FUNCTIONING PROPERLY ACCORDING TO MANUFACTURER'S SPECIFICATIONS. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481663 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC INC SDM-05000-2D3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown