Recall
FDAHealthSeptember 12, 2025

UIH Technologies LLC — Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

⚠️ Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.

Is this relevant to me?

Geography
US
Source agency
FDA
Category
Health
Published
September 12, 2025

US: OUS:

What's affected?

Product
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Lot code
UDI: (01)06971576831050/Serial Numbers: 684001, 684002

Additional details

UDI: (01)06971576831050/Serial Numbers: 684001, 684002

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.

View original FDA notice →

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