BEUDAMED
    FDA Enforcement Class II Ongoing

    YSIO X.Pree

    Recall: Z-0730-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0730-2022
    Event ID
    89738
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 7, 2022
    Classification Date
    April 5, 2022
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    YSIO X.Pree

    Reason

    For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.

    Code Info

    11107464

    Distribution

    US Nationwide, Worldwide distribution

    Quantity

    53 units