Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 ...
FDA Recall #Z-0218-2026 — Class II — September 12, 2025
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 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.
Recalling Firm
UIH Technologies LLC — Houston, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22 units
Distribution
US: OUS:
Code Information
UDI:(01)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated