UIH Technologies LLC is recalling 4 Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT systems sold in the United States. A third-party outer cover can become trapped between the patient table and gantry during table movement. Hospitals and clinics should stop using the devices and follow the manufacturer’s 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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The uMI Panorama 35 MD PET/CT System is a hybrid imaging device used in hospitals to produce fused PET and CT images for diagnostic purposes.
A third-party outer cover can become trapped between the patient table and gantry, leading to mechanical interference during movement and potential procedure disruption.
This recall is not described as part of a broader industry pattern.
The hazard can disrupt imaging workflows and potentially affect patient safety if the device is operated with the cover trapped.
Look for the recall letter and the device label showing model, UDI, and serial numbers.
Remediation timeline not specified by the manufacturer; expect communications by letter and facility coordination.
Keep the recall letter, document serial numbers and UDI, save all correspondence, and record remediation steps taken.
Model numbers: uMI Panorama 35 MD UDI: (01)06971576832170 Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001 Where sold: United States and international distribution When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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