Shanghai United Imaging Healthcare Co., Ltd. recalled two units of its uCT 780 MD Computed Tomography X-ray System on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, causing mechanical interference. This recall affects units distributed in the US and internationally.
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for instructions. Notification method: Letter
The recalled model is the uCT 780 MD Computed Tomography X-ray System. It has serial numbers 684001 and 684002. The devices were distributed in the US.
The recall involves a risk of mechanical interference during patient table movement. This can occur when third-party outer covers become trapped.
No specific incidents or injuries have been reported at this time. The hazard classification is considered high due to the potential for mechanical failure.
Stop using the device immediately. Follow the instructions provided by the manufacturer and contact UIH Technologies LLC for further guidance.
For more information, contact UIH Technologies LLC. Visit the FDA recall page for details at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0220-2026.
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