UIH Technologies recalled 2 units of the uCT 780 MD computed tomography system after an FDA enforcement notice Z-0220-2026. A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals should stop using the device immediately and await instructions from UIH Technologies LLC or their healthcare provider.
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
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CT scanners are used in medical facilities to create detailed internal body images for diagnosis. The UIH uCT 780 MD is a hospital-grade system intended for Rx-only use in clinical settings.
Outer covers from third-party components can become trapped between the patient table and gantry. This may interfere with table movement and imaging accuracy or safety.
This recall is not stated as part of a broader industry pattern.
Hospitals face potential procedure delays and equipment downtime. Patient safety depends on immediate action to prevent exposure to the risk during imaging.
UDI plate and device serial label on the scanner; recall letter from UIH Technologies LLC
Recall remedy timelines vary; plan for 4-8 weeks for service scheduling and completion
Keep the recall letter, device identifiers, and all correspondence with the manufacturer. Photograph labels and keep an audit trail for regulatory records
Brand: UIH Technologies (Shanghai United Imaging Healthcare)\nProduct: Computed Tomography X-ray System\nModel: uCT 780 MD\nSold to: Hospitals and healthcare facilities (US and international)\nWhen sold: Unknown\nPrice: Unknown\nDate recalled: 2025-09-12\nRecall notice: 2025-10-29\nRecall number: Z-0220-2026\nUnits recalled: 2\nUDI: 01)06971576831050\nSerial numbers: 684001, 684002\nCountry of origin: China
No injuries or incidents have been reported.
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