BEUDAMED
    FDA Recall 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 · Initiated January 25, 2021

    Recall

    Recall Number
    Z-1160-2021
    Event Number
    87289
    Firm
    Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
    FEI Number
    3011015597
    Product Code
    KPR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 25, 2021
    Terminated
    May 3, 2022

    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.

    Action

    On 01/25/2021, Shanghai United Imaging sent an Urgent: Medical Device Correction via: Email. In addition to informing consignees about the recall, the firm asked customers to take the following actions: 1. Once the RHA motor driver is powered on, and while the RHA motor is looking for the zero-position (before its first electric movements), please do not apply any external force to the TUI. 2. For further questions, please contact your United Imaging Service Engineer or call the United Imaging Customer Contact Center at our 24-hour hotline (855) 221-1552 (toll free) or (832) 699-2799 (direct). 3. Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regulatory mail or by fax. 4. Notify all users of the affected products via this Customer Notification Letter. 5. Please completed the Receipt of Customer Notification Letter form and return to United Imaging.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    6 units