BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1075-2022 · Initiated July 30, 2019

    Recall

    Recall Number
    Z-1075-2022
    Event Number
    90104
    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
    Software change control
    Initiated
    July 30, 2019
    Terminated
    May 17, 2022

    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.

    Action

    On 07/30/19, Customer Notification Letters started being distributed to customers. Customers were asked to contact the firm if they found an inconsistency between the protocol name and the positioning image. The following phone numbers were provided: (855) 221-1552 (toll free) or (832) 699-2799 (direct). The firm issued Field Correction Instructions to Service Engineers to modify the protocol name of Flexion and Extension on C-Spine & L-Spine with the corrected guidelines. In addition, the firm committed to permanently fix impacted systems with a software update.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    4