BEUDAMED
    FDA Enforcement Class II Terminated

    Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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-1708-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1708-2020
    Event ID
    85340
    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
    April 22, 2020
    Initiation Date
    August 26, 2019
    Classification Date
    April 15, 2020
    Termination Date
    May 18, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., Shanghai, N/A, China

    Description

    Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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

    Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.

    Code Info

    Serial Numbers: 200017 and 200023

    Distribution

    US Nationwide distribution in the state TX.

    Quantity

    2 units