FDA Device recall Z-3278-2026
Computed Tomography X-ray System, Model: uCT 550 with software
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Computed Tomography X-ray System, Model: uCT 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-3278-2026 |
| 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
Computed Tomography X-ray System, Model: uCT 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: 06971576831036. Serial Numbers/Software: 353021/R001.19.6.1857994-Re3300SP1H1_P5, 353045/R001.19.6.1857994-R…UDI-DI: 06971576831036. Serial Numbers/Software: 353021/R001.19.6.1857994-Re3300SP1H1_P5, 353045/R001.19.6.1857994-Re3300SP1H1_P5, 353049/R001.19.6.1857994-Re3300SP1H1_P5, 354001/R001.19.6.1857994-Re3300SP1H1_P5, 354004/R001.19.6.1857994-Re3300SP1H1_P5, 354005/R001.19.6.1857994-Re3300SP1H1_P5, 354007/R001.19.6.1857994-Re3300SP1H1_P5, 354009/R001.19.6.1857994-Re3300SP1H1_P5, 354013/R001.19.6.1857994-Re3300SP1H1_P5, 354015/R001.19.6.1857994-Re3300SP1H1_P5, 354016/R001.19.6.1857994-Re3300SP1H1_P5, 354018/R001.17.6.1607336-Re3100SP4, 354020/R001.17.6.1607336-Re3100SP4, 354021/R001.17.6.1607336-Re3100SP4, 354022/R001.19.4.1810621-Re3300SP1H1_P3, 354023/R001.19.6.1857994-Re3300SP1H1_P5, 354024/R001.19.6.1857994-Re3300SP1H1_P5, 354025/R001.19.6.1857994-Re3300SP1H1_P5, 354026/R001.19.6.1857994-Re3300SP1H1_P5, 354027/R001.19.6.1857994-Re3300SP1H1_P5, 354028/R001.19.6.1857994-Re3300SP1H1_P5, 354029/R001.19.6.1857994-Re3300SP1H1_P5, 354030/R001.19.6.1857994-Re3300SP1H1_P5 |
|---|
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-3278-2026%22
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