Shanghai United Imaging Healthcare Co., Ltd. recalled 11 units of its uCT 760 MD Computed Tomography X-ray System on September 12, 2025. The recall addresses a serious hazard where third-party outer covers can become trapped between the patient table and gantry, leading to mechanical interference. Healthcare providers and patients must stop using the device immediately and follow recall directives
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 Computed Tomography X-ray System, Model: uCT 760 MD. The recall affects 11 units distributed in the United States.
Third-party outer covers may become trapped between the patient table and gantry. This situation could cause mechanical interference during table movement, posing a risk to patient safety.
No specific incidents or injuries have been reported yet. The recall is proactive to prevent potential hazards.
Stop using the device immediately. Follow recall instructions from the manufacturer and contact UIH Technologies LLC or your healthcare provider for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0219-2026.
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