UIH Technologies recalls 3 units of Shanghai United Imaging Healthcare uMI 780 PET/CT systems after a third-party outer cover can trap between the patient table and gantry. The issue can obstruct table movement. Hospitals are urged to stop using the devices and follow recall 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
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PET/CT systems merge functional imaging with CT for diagnostic purposes. They are used in hospitals for oncology and other imaging needs.
A third-party outer cover can become trapped between table and gantry, interfering with table movement and potentially affecting imaging procedures.
This recall is not part of a broader industry pattern.
Direct impact on hospital workflows and patient safety during imaging; no injuries reported in the notice.
FDA recall page Z-0224-2026, manufacturer recall letters
Remedy and next steps will be provided by manufacturer; follow-up actions may include repair or replacement within weeks to months
Keep recall notice, serial numbers, service reports, and any replacement paperwork
Model: uMI 780 MD, Rx Only. Quantity: 3 units. Distribution: US only. Recall date: 2025-09-12. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Recall status: ACTIVE. Notification method: Letter. 3 units affected in the US market.
No specific injuries or incidents are detailed in the recall notice. Hazard classified as HIGH risk.
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