Shanghai United Imaging Healthcare recalled two units of the uCT ATLAS MD X-ray system on September 12, 2025. The recall follows reports that third-party outer covers can trap between the patient table and gantry, leading to mechanical interference. Healthcare providers and patients must cease use immediately and follow manufacturer instructions.
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 recall involves the uCT ATLAS MD Computed Tomography X-ray System. Two units were distributed in the U.S. The affected serial numbers are 863001 and 863002.
The outer covers from third-party manufacturers can become trapped between the patient table and the gantry. This creates a risk of mechanical interference during table movement, potentially endangering patients.
No incidents or injuries have been reported as of the recall date. The product poses a high hazard level due to mechanical interference risks.
Stop using the affected X-ray system immediately. Follow the recall instructions provided by UIH Technologies. Contact your healthcare provider or UIH Technologies for additional guidance.
For more information, reach out to UIH Technologies LLC. Visit their website or refer to the notification letter sent to healthcare providers.
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