BEUDAMED
    FDA Recall Open, Classified

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    Recall: Z-1353-2023 · Initiated March 1, 2023

    Recall

    Recall Number
    Z-1353-2023
    Event Number
    91870
    Firm
    Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
    FEI Number
    3011015597
    Product Code
    KPS
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 1, 2023
    Posted
    April 7, 2023

    Description

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    Reason

    Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.

    Action

    On 03/01/2023, the firm sent an "Advisory Notification: Positron Emission Tomography and Computed Tomography System (PET/CT)" Letter via email to customers informing them that, the scatter correction may fail due to GPU (Graphic Processing Unit) memory access exception. The failure of the scatter correction could result in the failure of the PET image reconstruction. Customers are instructed to: 1. if the default PET image reconstruction fails with an error information of abnormal GPU status, but the reconstruction without either attenuation correction or scatter correction works successfully, the following actions are suggested to be applied: 1) Try using the diagnostic CT image series instead of ACCT image series for attenuation correction to repeat the PET reconstruction. It may resolve the error issue, but the quantification of PET image might be affected due to attenuation correction with using the limited field of view of diagnostic CT image. If the resulted PET image is insufficient for diagnosis, try second suggestion. 2) Try re-perform the PET acquisition, the reconstruction may succeed. 3) Contact the United Imaging service engineer to install the updated software to resolve the issue, and offline reconstruct the PET image. For questions, contact United Imaging service engineer or call the United Imaging Customer Contact Center (24- hour hotline) at 855-221-1552 (toll-free) or 832-699-2799 (direct).

    Distribution

    U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.

    Quantity

    47 systems (U.S. only)