FDA-Device2026-10-07Class IIPROCESSING DEFECT

Shanghai United Imaging uMI Panorama 35 PET/CT system recalled for software visibility issue

OTHERNationwide distributionMedical devices

What this means

Certain uMI Panorama 35 PET/CT systems have a software problem that can hide patient images from the display when specific functions are enabled and multiple exams are combined. This may require patients to undergo repeat scans.

If your facility operates an affected uMI Panorama 35 system, contact Shanghai United Imaging Healthcare for a software update or corrective action.
Check the serial numbers on the FDA notice to confirm if your system is affected.
Do not merge multiple exams into a single study using the Split or Local function until the issue is resolved.

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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

Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3284-2026

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