BEUDAMED
    FDA Recall Open, Classified

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

    Recall: Z-0224-2026 · Initiated September 12, 2025

    Recall

    Recall Number
    Z-0224-2026
    Event Number
    97668
    Firm
    UIH Technologies LLC
    FEI Number
    3014809646
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    September 12, 2025
    Posted
    October 21, 2025
    Address
    9380 Kirby Dr, Houston, TX, 77054-2515

    Description

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

    Reason

    Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

    Action

    On September 12, 2025, UIH Technologies LLC, issued a recall notification to affected consignees. UIH asked consignees to take the following actions: 1. Ensure patient positioning clearance: When positioning the patient, confirm that arms and legs and clear of all table gaps and moving parts. 2. Avoid use of third-party slickers: We advise against the use of any non-UIH-approved slickers. 3. Service Contact: For technical assistance, contact your United Imaging Service engineer or reach out to our 24/7 Customer Contact Center, Toll-Free: (855) 221-1552/Direct: (832) 699-2799 4.Report adverse events: if any adverse events or quality issue occur, please report them to the FDA via the MedWatch program. 5. Please share this information with all relevant personnel at your facility, including technologist, service staff, and clinical teams.

    Distribution

    US: OUS:

    Quantity

    3 units