UIH Technologies LLC recalls eight Shanghai United Imaging uCT 530 MD CT scanners sold to U.S. hospitals. Third‑party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals should stop using the device immediately and follow recall instructions from UIH Technologies 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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The uCT 530 MD is a computed tomography imaging system used in hospitals to produce diagnostic CT scans. It is designed for Rx-only use in clinical settings.
A third-party outer cover can become trapped between the patient table and gantry, potentially causing mechanical interference during table movement and imaging procedures.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals must halt use of the affected units to prevent possible imaging disruption or injury, with potential financial and operational disruption during replacement or inspection.
Recall details at FDA enforcement page Z-0217-2026 and manufacturer recall notices. The UDI and serial numbers appear on the device label and in the recall notice.
UIH Technologies LLC will provide next steps and remediation timelines in the recall notice; timelines are not specified in the provided data.
Keep copies of the recall letter, FDA notice, device labels showing model/UDI/serial numbers, and all communications with the manufacturer.
Brand: Shanghai United Imaging Healthcare Co., Ltd. (UIH Technologies LLC is the U.S. distributor) Product: Computed Tomography X-ray System, Model uCT 530 MD (Rx Only) Serial Numbers: 300162, 300163, 300174, 300176, 304002, 304003, 304004, 304006 UDI: (01)06971576831012 Quantity: 8 units Sold in the U.S.: Yes When sold: Unknown Price: Unknown Recall date: 2025-09-12 Recall status: ACTIVE
No injuries or incidents have been reported.
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