UIH Technologies LLC recalled 95 uMI 550 MD PET/CT systems sold in the United States after reports that third-party outer covers can become trapped between the patient table and gantry. The covers can interfere with table movement during imaging. Hospitals and clinics should stop using the devices and follow the manufacturer's recall instructions immediately.
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 uMI 550 MD PET/CT system is a medical imaging device used for combined PET and CT scans in clinical settings. It is used by hospitals and imaging centers for diagnostic imaging.
A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. This may affect imaging procedures or cause patient risk if the table moves unexpectedly.
This recall is not described as part of a broader industry pattern in the notice.
The issue can interrupt imaging workflows and potentially disrupt patient positioning or image quality until resolved.
Identifiers are on the device label and data plate. See the FDA recall page for the full serial-number list.
Remedy processing timelines are determined by the manufacturer; the recall page does not specify a timetable.
Keep the recall letter, record all communications with the manufacturer and healthcare facility, and photograph the device label and covers.
Model: uMI 550 MD. Classification: Class II. Quantity: 95 units. Distribution: United States. Distributor/Manufacturer: Shanghai United Imaging Healthcare Co., Ltd. Recall date: 2025-09-12.
No injuries or incidents have been reported.
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