BEUDAMED
    FDA Enforcement Class II Ongoing

    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    Recall: Z-2704-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2704-2020
    Event ID
    85868
    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
    August 5, 2020
    Initiation Date
    June 20, 2020
    Classification Date
    July 27, 2020
    Address
    No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China

    Description

    Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular).

    Reason

    The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

    Code Info

    SN 300162, 300163, 300174, 300176

    Distribution

    US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.

    Quantity

    4