Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomograp...
FDA Recall #Z-0224-2026 — Class II — September 12, 2025
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Recalling Firm
UIH Technologies LLC — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3 units
Distribution
US: OUS:
Code Information
UDI: (01)06971576832033/ Serial Number: 300072, 300082, 300098
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated