FDA-Device2026-10-07Class IIPROCESSING DEFECT

Shanghai United Imaging uMI 780 PET/CT system recalled for software visibility issue

OTHERNationwide distributionMedical devices

What this means

A software problem in the Shanghai United Imaging uMI 780 PET/CT system 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 this system, contact Shanghai United Imaging Healthcare for a software update or corrective action.
Do not perform merged exams using the Split or Local function until the issue is resolved.
Verify that patient images are visible on the administration interface before completing any study.

Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓

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 780

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3288-2026

More United Imaging recalls

FDA-Device2026-10-07
Shanghai United Imaging uMI 550 PET/CT system recalled for software display issue
FDA-Device2026-10-07
Shanghai United Imaging uMI Panorama GS PET/CT system recalled for software visibility issue
FDA-Device2026-10-07
Shanghai United Imaging uCT 760 CT system recalled for software visibility issue
FDA-Device2026-10-07
Shanghai United Imaging uMI Panvivo PET/CT system recalled for software visibility issue
FDA-Device2026-10-07
Shanghai United Imaging uCT ATLAS Astound CT system recalled for software visibility issue

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.