[pending] Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography
Pending LLM rewrite. Source: FDA_DEVICE Z-0225-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
The recalled product
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
- Manufacturer
- UIH Technologies LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: (01)06971576832170/ Serial numbers: 11MI410003
- 11MI410004
- 11MI410005
- 20MI410001
Distribution
Distribution scope not specified by the agency.
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