BEUDAMED
    FDA Enforcement Class II Terminated

    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    Recall: Z-1075-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1075-2022
    Event ID
    90104
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shanghai United Imaging Healthcare Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    July 30, 2019
    Classification Date
    May 12, 2022
    Termination Date
    May 17, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China

    Description

    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    Reason

    X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.

    Code Info

    DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    4