BEUDAMED
    FDA Enforcement Class II Terminated

    uCT 760 System, Computed Tomography X-ray System

    Recall: Z-2522-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2522-2020
    Event ID
    85804
    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
    July 15, 2020
    Initiation Date
    May 8, 2020
    Classification Date
    July 6, 2020
    Termination Date
    January 20, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., Shanghai, N/A, China

    Description

    uCT 760 System, Computed Tomography X-ray System

    Reason

    Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

    Code Info

    Model uCT 760; Serial Numbers: 600229, 600230, 600232, 600271 with software version R001.11.0.729741-Re-1100, and serial number 600282 with software version R001.11.0.785930-Re-1150.

    Distribution

    Distributed to two customers. Both customers located in Houston, Texas.

    Quantity

    5 units