BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0999-2026 · Initiated December 5, 2025

    Recall

    Recall Number
    Z-0999-2026
    Event Number
    98230
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    December 5, 2025
    Posted
    January 8, 2026
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    The Customer Advisory Notice (CAN) was sent to the affected customer on December 5, 2025. The CAN notifies the customer of the problem and provides steps the user should take to avoid the problem until the resolution software update is available. When switching within five seconds from a table related OGP to a bucky wall stand related OGP with top-alignment and then back to a table related OGP, it may happen, that the collimation is not adapted to the limitations of the detector. The active radiation field may thus extend beyond the limits of the detector, resulting in radiation outside of the area of the detector.

    Distribution

    U.S. and OUS

    Quantity

    U.S.: 1, OUS: 95