Computed Tomography X-ray System recall (Shanghai United Imaging Healthcare Co., Ltd.)
Medical deviceClass IIOngoing
Summary: Shanghai United Imaging Healthcare Co., Ltd. is recalling Computed Tomography X-ray System, Model: uCT ATLAS 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 ATLAS 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: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4, 863004/R001.17.6.1607336-Re3100SP4, 863005/R001.17.6.1607336-Re3100SP4, 863007/R001.21.0.1897081-Re3310SP1, 863008/R001.21.0.1897081-Re3310SP1, 869001/R001.22.0.2012850-Re3320, 869002/R001.19.4.1810621-Re3300SP1H1_P3, 869003/R001.21.0.1897081-Re3310SP1, 869004/R001.21.0.1897081-Re3310SP1, 11CT863010/R001.17.6.1607336-Re3100SP4
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-3281-2026 |
| 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 | 11 |
More recalls from Shanghai United Imaging Healthcare Co., Ltd. · all medical device recalls · recalls from August 2026