Recall Z-3283-2026 ยท KPS System, Tomography, Computed, Emission
Shanghai United Imaging Healthcare Co., Ltd.
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
| Date | Sep 25, 2026 (initiated Aug 11, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On 8/11/2026, correction notices were emailed to customers informing them that software will be released to resolve the software problem. Customers were asked to do the following: When using the Study Split function, follow the requirements below: 1) Temporarily disable the "Study Split" function. Navigate to the system configuration interface and uncheck the "Auto Study Split" option. 2) If the "Study Split" function is clinically necessary, open the system configuration interface and select "Split on PACS" instead of "Split on Local". 3) When "Auto study split" is checked, ensure that PACS ( |
| Quantity | 34 |
| Distribution | 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. |
| FDA record | Open on fda.gov |