UIH Technologies recalled 95 units of its uMI 550 Positron Emission Tomography and Computed Tomography System on September 12, 2025. Third-party outer covers can trap between the patient table and gantry, posing a mechanical interference risk. Patients and healthcare providers must stop using the device 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
The recall affects the uMI 550 model, classified as Rx Only. The devices were distributed in the US and other countries.
The recall stems from a mechanical hazard where third-party outer covers can become trapped during table movement. This interference can lead to serious operational issues.
No injuries or incidents have been reported related to this recall. However, the potential for mechanical interference poses a significant risk.
Stop using the device immediately. Contact UIH Technologies LLC or your healthcare provider for further instructions regarding the recall.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0223-2026.
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