FDA Medical devices recall ·
Shanghai United Imaging Healthcare Co., Ltd recall
- Recall number
- Z-0222-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- UIH Technologies LLC
9380 Kirby Dr, Houston, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 UNITS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Why was it recalled?
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: (01)06971576832040; Serial Number: F00002, F00015
Distribution
US: OUS:
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0222-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.