FDA-Device2026-10-07Class IIPROCESSING DEFECT

Shanghai United Imaging uCT 530 CT scanner recalled for software visibility issue

OTHERNationwide distributionMedical devices

What this means

A software problem in the uCT 530 computed tomography scanner can prevent patient images from appearing on the Patient Administration interface when certain functions are enabled and multiple exams are merged. This may require patients to undergo repeat scans.

If your facility operates an affected uCT 530 scanner (serial numbers 300174, 304006, 304007, or 304008), contact Shanghai United Imaging Healthcare for a software update.
Do not merge multiple RIS exams into a single study using the Split or Local function until the update is applied.

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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

Adults

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 530 with software

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3277-2026

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