BEUDAMED
    FDA Enforcement Class II Ongoing

    Phoenix mKDR Xpress, digital mobile diagnostic x-ray system

    Recall: Z-1203-2023 · Reported March 8, 2023

    Enforcement

    Recall Number
    Z-1203-2023
    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 Xpress, 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 08436046003163, Serial Numbers: PH00202, PH00203, PH00204, PH00205, PH00206, PH00207, PH00208

    Distribution

    US, Argentina, Panama

    Quantity

    7 units