FDA Device recall Z-3281-2026
Computed Tomography X-ray System, Model: uCT ATLAS 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 ATLAS 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-3281-2026 |
| 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 ATLAS 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: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP…UDI-DI: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4, 863004/R001.17.6.1607336-Re3100SP4, 863005/R001.17.6.1607336-Re3100SP4, 863007/R001.21.0.1897081-Re3310SP1, 863008/R001.21.0.1897081-Re3310SP1, 869001/R001.22.0.2012850-Re3320, 869002/R001.19.4.1810621-Re3300SP1H1_P3, 869003/R001.21.0.1897081-Re3310SP1, 869004/R001.21.0.1897081-Re3310SP1, 11CT863010/R001.17.6.1607336-Re3100SP4 |
|---|
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 - Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
FDA Device · Class II · 2026-10-07 · Shanghai United Imaging Healthcare - Positron Emission Tomography and Computed Tomography System, Model: uMI 550 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-3281-2026%22
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