Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)

Q: Is Computed Tomography X-ray System (Shanghai United Imaging Healthcare Co., Ltd.) recalled?

Yes. Shanghai United Imaging Healthcare Co., Ltd. is recalling Computed Tomography X-ray System, Model: uCT 780 with software. Reason: 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. The recall started August 11, 2026 and its status is ongoing. Recall number Z-3280-2026.

Medical deviceClass IIOngoing

Summary: Shanghai United Imaging Healthcare Co., Ltd. is recalling Computed Tomography X-ray System, Model: uCT 780 with software. Reason: 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.

What is being recalled

Computed Tomography X-ray System, Model: uCT 780 with software

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: Alabama, California, Colorado, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Wisconsin, West Virginia)

How to tell if yours is affected

UDI-DI: 06971576831050. Serial Number/Software: 684001/R001.17.6.1607336-Re3100SP4, 684002/R001.17.6.1607336-Re3100SP4, 684003/R003.8.4.1810621-Re3300SP1H1_P3, 684004/R003.8.4.1810621-Re3300SP1H1_P3, 684005/R003.8.4.1810621-Re3300SP1H1_P3, 684006/R003.8.4.1810621-Re3300SP1H1_P3, 684007/R003.8.4.1810621-Re3300SP1H1_P3, 684008/R003.8.4.1810621-Re3300SP1H1_P3, 684009/R003.8.4.1810621-Re3300SP1H1_P3, 684010/R003.8.4.1810621-Re3300SP1H1_P3, 684011/R003.8.4.1810621-Re3300SP1H1_P3, 684012/R003.9.0.1776134-Re-3300SP2, 684013/R003.11.0.1897081-Re3310SP1, 684014/R003.11.0.1897081-Re3310SP1

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall number	Z-3280-2026
Category	Medical device
Agency	U.S. Food and Drug Administration (FDA)
Severity	Class II
Status	Ongoing
Recall started	August 11, 2026
Reported	October 7, 2026
Company	Shanghai United Imaging Healthcare Co., Ltd.
Company location	Shanghai, China
Initiated by	Voluntary: Firm initiated
Quantity	14

More recalls from Shanghai United Imaging Healthcare Co., Ltd. · all medical device recalls · recalls from August 2026

Official FDA record