BEUDAMED
    FDA Enforcement Class II Ongoing

    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    Recall: Z-0447-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0447-2021
    Event ID
    86269
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shanghai United Imaging Healthcare Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 18, 2020
    Initiation Date
    August 5, 2020
    Classification Date
    November 12, 2020
    Address
    No. 2258 Chengbei Rd, Jiading Ind., Shanghai, N/A, China

    Description

    Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular).

    Reason

    A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.

    Code Info

    Serial Numbers: 600229, 600230, 600232, 600271, 600282

    Distribution

    US Nationwide distribution including in the state of TX.

    Quantity

    5