Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Reported: October 29, 2025 Initiated: September 12, 2025 #Z-0223-2026
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Details
- Recalling Firm
- UIH Technologies LLC
- Units Affected
- 95 units
- Distribution
- US: OUS:
- Location
- Houston, TX
Frequently Asked Questions
What product was recalled? ▼
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only. Recalled by UIH Technologies LLC. Units affected: 95 units.
Why was this product recalled? ▼
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0223-2026.
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