FDAClass IIOctober 29, 2025

Shanghai United Imaging Healthcare Co recall

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 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)06971576831050/Serial Numbers: 684001, 684002

Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Recalling firm
UIH Technologies LLC
Quantity
2 units
Distribution
US: OUS:
Recall date
October 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls