Device product

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

Z-0218-2026

September 12, 2025

Class II

Product summary

Firm: UIH Technologies LLC
Event: Event 97668
Status: Ongoing
Classification: Class II
Quantity: 22 units
Official record key: device-enforcement:Z-0218-2026

Official wording

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

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

Distribution pattern: US: OUS:

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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