Shanghai United Imaging Healthcare Co., Ltd. — Computed Tomography X-ray System, Model: uCT 550 with software

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Provider

FDA — device enforcement reference

Source observed

8/11/2026, 12:00:00 AM UTC

Source updated

9/25/2026, 12:00:00 AM UTC

Location

Shanghai, US

hazard

Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

notice

Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.

product

Computed Tomography X-ray System, Model: uCT 550 with software

distribution

US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.

event number

99731

manufacturer

Shanghai United Imaging Healthcare Co., Ltd.

recall number

Z-3278-2026

source status

Open, Classified

freshness minutes

180

Source use policy · openFDA reference data; not a real-time public alert service

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