BEUDAMED
    FDA Enforcement Class II Ongoing

    Phoenix mKDR, digital mobile diagnostic x-ray system

    Recall: Z-1202-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1202-2023
    Event ID
    91656
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SEDECAL SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 8, 2023
    Initiation Date
    February 6, 2023
    Classification Date
    March 2, 2023
    Address
    PELAYA, 9 POL., POL. IND. RIO DE JANEIRO, Algete, N/A, N/A, Spain

    Description

    Phoenix mKDR, digital mobile diagnostic x-ray system

    Reason

    Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

    Code Info

    UDI/DI 08436046003002, Serial Numbers: PH00092, PH00093, PH00094, PH00095, PH00097, PH00098, PH00099, PH00100, PH00110, PH00111, PH00112, PH00113, PH00114, PH00115, PH00116, PH00117, PH00118, PH00135, PH00136, PH00137, PH00138, PH00139, PH00140, PH00141, PH00142, PH00143, PH00144, PH00161, PH00162, PH00163, PH00164, PH00165, PH00166, PH00167, PH00168, PH00169, PH00176, PH00177, PH00178, PH00179, PH00180, PH00181, PH00185, PH00186, PH00187, PH00188, PH00189, PH00190, PH00191, PH00192, PH00010, PH00090, PH00091

    Distribution

    US, Argentina, Panama

    Quantity

    53 units