BEUDAMED
    FDA Enforcement Class II Ongoing

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    Recall: Z-2167-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2167-2026
    Event ID
    98566
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2026
    Initiation Date
    April 8, 2026
    Classification Date
    May 12, 2026
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020, United States

    Description

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    Reason

    Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

    Code Info

    "Model No.; UDI": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.

    Distribution

    US Nationwide distribution.

    Quantity

    4,305 units