United Imaging Computed Tomography and Positron Emission Tomography Systems
The systems have a software problem when Split or Local function is enabled and multiple RIS exams are merged into a single study.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Shanghai United Imaging Healthcare Co., Ltd. recalled Computed Tomography X-ray Systems and Positron Emission Tomography and Computed Tomography Systems because a software problem, when Split or Local function is enabled and multiple RIS exams are merged into a single study, prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
The recall began August 11, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Positron Emission Tomography and Computed Tomography System
- Model
- uMI
Computed Tomography X-ray System
- Model
- uCT
Computed Tomography X-ray System, Model: uCT 530 with software
- UDI-DI
- 06971576831012
Computed Tomography X-ray System, Model: uCT 760 with software
- UDI-DI
- 06971576831043
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
- UDI-DI
- 06971576832033
Computed Tomography X-ray System, Model: uCT 550 with software
- UDI-DI
- 06971576831036
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- UDI-DI
- 06971576832170
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
- UDI-DI
- 06971576831340
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
- UDI-DI
- 06971576832187
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
- UDI-DI
- 06971576832255
Computed Tomography X-ray System, Model: uCT 780 with software
- UDI-DI
- 06971576831050
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
- UDI-DI
- 06971576832231
Computed Tomography X-ray System, Model: uCT ATLAS with software
- UDI-DI
- 06971576831104
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
- UDI-DI
- 06971576832026
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, PR, Utah, West Virginia, North Dakota, Nebraska, North Carolina, Texas, Idaho, Louisiana, Montana, Florida, Colorado, Indiana, Kentucky, Alabama, Ohio, Michigan, Iowa, Missouri, New York, Nevada, Tennessee, West Virginia, South Carolina, Wisconsin, Illinois, Mississippi, Massachusetts, New Jersey.
- Event ID
- 99731
- Recall numbers
- Z-3277-2026 to Z-3288-2026
- Company
- Shanghai United Imaging Healthcare Co., Ltd.Shanghai, China
- Hazard
- Software defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
