Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomograp...
FDA Recall #Z-0225-2026 — Class II — September 12, 2025
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 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
4 unit
Distribution
US: OUS:
Code Information
UDI: (01)06971576832170/ Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated