BEUDAMED
    FDA Enforcement Class II Ongoing

    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

    Recall: Z-1174-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1174-2026
    Event ID
    98244
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2026
    Initiation Date
    December 29, 2025
    Classification Date
    January 27, 2026
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02

    Reason

    Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

    Code Info

    Siemens Material Number (SMN): 11574002; UDI-DI: 04056869993973; Serial Numbers: 150050, 150035, 150033, 150034, 150048, 150021, 150020, 150053, 150023, 150044, 150049, 150037, 150054, 150011, 150059, 150024, 150038, 150051, 150029, 150045, 150032, 150056, 150043, 150055, 150041, 150026, 150025, 150022, 150031, 150039, 150046, 150042, 150028, 150047, 150030, 150052, 150027, 150057, 150040, 150058, 150063;

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY, OR, VA, WI and the countries of Austria, Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland.

    Quantity

    41 units