UIH Technologies LLC: Device Recall
Recall #Z-0223-2026 · 09/12/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0223-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- UIH Technologies LLC
- Status
- Ongoing
- Date Initiated
- 09/12/2025
- Location
- Houston, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 units
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Distribution Pattern
US: OUS:
Other Recalls by UIH Technologies LLC
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.