Shanghai United Imaging Healthcare Co., Ltd. recalled four units of its Positron Emission Tomography and Computed Tomography System on September 12, 2025. The recall stems from a risk of mechanical interference during table movement due to third-party outer covers. Healthcare providers and patients 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 includes the uMI Panorama 35 model with serial numbers 11MI410003, 11MI410004, 11MI410005, and 20MI410001. The devices were distributed in the US and internationally. The classification of this recall is Class II.
Third-party outer covers can become trapped between the patient table and gantry. This interference can hinder the correct operation of the device, posing a mechanical risk during patient examinations.
No specific incidents or injuries have been reported as a result of this hazard. The recall aims to prevent potential mechanical issues before they occur.
Stop using the device immediately. Follow recall instructions provided by the manufacturer. Contact UIH Technologies LLC or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0225-2026.
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