BEUDAMED
    FDA Enforcement Class II Terminated

    Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

    Recall: Z-1160-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1160-2021
    Event ID
    87289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shanghai United Imaging Healthcare Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    January 25, 2021
    Classification Date
    March 2, 2021
    Termination Date
    May 3, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., Shanghai, N/A, China

    Description

    Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

    Reason

    There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.

    Code Info

    Serial Number: 270012, 270013, 270014, 270015, 270016, 270017

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    6 units