FDA Device recall Z-3283-2026
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software by Shanghai United Imaging Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3283-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-11 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
Product
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 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.
Identifiers
| code_info | UDI-DI: 06971576832026. Serial Number/Software: 200045/R001.19.0.1812568, 200163/R001.19.3.2011750, 200164/R001.18.…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Shanghai United Imaging Healthcare
- Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Computed Tomography X-ray System, Model: uCT 530 with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Computed Tomography X-ray System, Model: uCT ATLAS with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare
All Shanghai United Imaging Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3283-2026%22
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