Recall Z-0225-2026— UIH Technologies LLC
Class II · Ongoing
Class II FDA medical device recall by UIH Technologies LLC, initiated 2025-09-12. It names 2 FDA 510(k) clearances: K232712, K223325. Product: Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only. Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement..
- Recalling firm
- UIH Technologies LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-12
- Firm location
- Houston, TX, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Reason for recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Data sourced from openFDA. This site is unofficial and independent of the FDA.