BEUDAMED
    FDA Enforcement Class II Ongoing

    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

    Recall: Z-1002-2023 · Reported January 25, 2023

    Enforcement

    Recall Number
    Z-1002-2023
    Event ID
    91383
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2023
    Initiation Date
    December 9, 2022
    Classification Date
    January 19, 2023
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

    Reason

    There is potential for the footrest to detach from the patient table during use. Device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. These devices are not for mammography examinations.

    Code Info

    All serial numbers 1) Luminos Agile Max, Material #10762472, UDI/DI: 4056869009162 2) Luminos drF Max, Material #10762471, UDI/DI: 4056869009155 3) Luminos Lotus Max, Material #11574100, UDI/DI: 4056869269331

    Distribution

    Worldwide distribution

    Quantity

    886 units