BEUDAMED
    FDA Enforcement Class II Ongoing

    uCT 530 Computed Tomography X-Ray System

    Recall: Z-2472-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2472-2020
    Event ID
    85809
    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
    July 8, 2020
    Initiation Date
    May 8, 2020
    Classification Date
    June 30, 2020
    Address
    No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China

    Description

    uCT 530 Computed Tomography X-Ray System

    Reason

    Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

    Code Info

    Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).

    Distribution

    Distributed to Texas.

    Quantity

    4 units