FDAHealthSeptember 12, 2025
UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
⚠️ Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- September 12, 2025
US: OUS:
What's affected?
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
- Brand
- UIH Technologies LLC
- Lot code
- UDI: (01)06971576832040; Serial Number: F00002, F00015
Additional details
UDI: (01)06971576832040; Serial Number: F00002, F00015
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2 UNITS.
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