FDA-Device2026-10-07Class IIPROCESSING DEFECT

Shanghai United Imaging uCT ATLAS CT system recalled for software visibility issue

OTHERNationwide distributionMedical devices

What this means

Certain uCT ATLAS computed tomography systems have a software problem that can hide patient images from the Patient Administration interface when specific functions are enabled and multiple exams are merged. This may require patients to undergo repeat scans.

If your facility operates a uCT ATLAS system, contact Shanghai United Imaging to determine if your device is affected by checking your serial number and software version.
Do not merge multiple RIS exams into a single study when Split or Local function is enabled until you receive a software update.
Keep all affected patient records and repeat scan documentation for your records.

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The agency's original wording

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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.

Affected count

Manufactured in

No. 2258 Chengbei Rd, Jiading Ind., Shanghai, China

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3281-2026

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