Device recall
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
- Recall number
- Z-3283-2026
- Event id
- 99731
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 11, 2026
- Center classification date
- Sep 25, 2026
- Product code
- KPS
- Device type
- System, Tomography, Computed, Emission
- 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
- Quantity
- 34
- Code info
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Shanghai, China