BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1002-2023 · Initiated December 9, 2022

    Recall

    Recall Number
    Z-1002-2023
    Event Number
    91383
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 9, 2022
    Posted
    January 20, 2023
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    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.

    Action

    A Customer Safety Advisory Notification (CSAN) was distributed to affected consignees beginning December 9, 2022. The CSAN was distributed to inform the customers about a preventative measure to exclude any potential risk of patient injury caused by the footrest detaching from the patient table during examination. Together with the CSAN, an addendum to the operator manual is distributed containing additional details and illustrations on how to securely attach the footrest to further improve the understanding of handling the footrest. Refer to the CSAN with addendum and copies of the Instructions for Use for each reported system.

    Distribution

    Worldwide distribution

    Quantity

    886 units