BEUDAMED
    FDA Enforcement Class II Ongoing

    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

    Recall: Z-0999-2026 · Reported January 14, 2026

    Enforcement

    Recall Number
    Z-0999-2026
    Event ID
    98230
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Report Date
    January 14, 2026
    Initiation Date
    December 5, 2025
    Classification Date
    January 8, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

    Reason

    A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

    Code Info

    (01)04056869269931(21)10330

    Distribution

    U.S. and OUS

    Quantity

    U.S.: 1, OUS: 95