Shanghai United Imaging Healthcare Co recall
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Why was Shanghai United Imaging Healthcare Co recalled?
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)06971576832170/ Serial numbers: 11MI410003, 11MI410004, 11MI410005, 20MI410001
- Product
- Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
- Recalling firm
- UIH Technologies LLC
- Quantity
- 4 unit
- Distribution
- US: OUS:
- Recall date
- October 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)