BEUDAMED
    FDA Enforcement Class II Ongoing

    Positron Emission Tomography and Computed Tomography System, Model: uMI 550

    Recall: Z-0087-2023 · Reported October 19, 2022

    Enforcement

    Recall Number
    Z-0087-2023
    Event ID
    90888
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Shanghai United Imaging Healthcare Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2022
    Initiation Date
    May 30, 2022
    Classification Date
    October 13, 2022
    Address
    No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China

    Description

    Positron Emission Tomography and Computed Tomography System, Model: uMI 550

    Reason

    The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.

    Code Info

    UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027, 230028, 230029, 230030, 230031, 230032, 230033, 232001

    Distribution

    Distribution to US states of TX, WI, CA, and MI

    Quantity

    32