BEUDAMED
    FDA Enforcement Class II Terminated

    uEXPLORER PET/CT Diagnostic Imaging System - 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-2799-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2799-2020
    Event ID
    85948
    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
    August 19, 2020
    Initiation Date
    July 16, 2020
    Classification Date
    August 13, 2020
    Termination Date
    July 7, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China

    Description

    uEXPLORER PET/CT Diagnostic Imaging System - 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

    1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.

    Code Info

    Serial No. F00002; GTIN 06971576832040

    Distribution

    US Nationwide distribution including in the state of Texas.

    Quantity

    1 unit distributed to Texas