BEUDAMED
    FDA Enforcement Class II Ongoing

    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    Recall: Z-0448-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0448-2021
    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

    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    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: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004

    Distribution

    US Nationwide distribution including in the state of TX.

    Quantity

    9