Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Published October 7, 2026 · Recall initiated: August 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Distributor
- 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.
- Lot
- UDI-DI: 06971576832026. Serial Number/Software: 200045/R001.19.0.1812568, 200163/R001.19.3.2011750, 200164/R001.18.0.1683822, 200165/R001.18.0.1683822, 200166/R001.18.0.1683822, 200167/R001.18.0.1683822, 202009/R001.19.3.2011750, 202016/R001.19.0.1812568, 202018/R001.19.0.1812568, 202019/R001.19.0.1812568, 202020/R001.19.1.1929746, 202021/R001.19.1.1929746, 202022/R001.19.1.1929746, 230040/R001.19.3.2011750, 230048/R001.19.0.1812568, 230106/R001.19.0.1812568, 232038/R001.19.0.1812568, 232039/R001.19.0.1812568, 232040/R001.19.0.1812568, 232041/R001.19.0.1812568, 232042/R001.19.0.1812568, 232043/R001.19.0.1812568, 232044/R001.19.0.1812568, 232045/R001.19.0.1812568, 232046/R001.19.0.1812568, 232047/R001.19.0.1812568, 232048/R001.19.1.1929746, 232049/R001.19.1.1929746, 232050/R001.19.1.1929746, 232051/R001.19.1.1929746, 202023/R001.19.1.1929746, 202024/R001.19.1.1929746, 232052/R001.19.1.1929746, 232053/R001.19.1.1929746
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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Questions about this recall
Was Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software recalled?
Yes. FDA published recall Z-3283-2026 on October 7, 2026. Reported 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.
What should I do if I have this product?
Voluntary: Firm initiated
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