FDA Device recall Z-3282-2026
Computed Tomography X-ray System, Model: uCT ATLAS Astound 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 Astound 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-3282-2026 |
| 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 Astound 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: 06971576831340. Serial Number/Software: 803011/R002.9.0.1897081-Re3310SP1, 803012/R002.4.6.1607336-Re3100SP4…UDI-DI: 06971576831340. Serial Number/Software: 803011/R002.9.0.1897081-Re3310SP1, 803012/R002.4.6.1607336-Re3100SP4, 803013/R002.4.6.1607336-Re3100SP4, 803014/R002.9.0.1897081-Re3310SP1, 803016/R002.4.6.1607336-Re3100SP4, 803017/R002.9.0.1897081-Re3310SP1, 803018/R002.9.0.1897081-Re3310SP1, 803019/R002.4.6.1607336-Re3100SP4, 803020/R002.9.0.1897081-Re3310SP1, 803022/R002.9.0.1897081-Re3310SP1, 803023/R002.9.0.1897081-Re3310SP1, 803024/R002.9.0.1897081-Re3310SP1, 809001/R002.8.1.1840891-Re3310A_P1, 809002/R002.9.0.1897081-Re3310SP1, 809003/R002.8.1.1840891-Re3310A_P1, 809004/R002.4.6.1607336-Re3100SP4, 809005/R002.4.6.1607336-Re3100SP4, 809006/R002.8.1.1840891-Re3310A_P1, 809007/R002.4.7.1671762-Re3100SP4_P1, 809008/R002.4.7.1671762-Re3100SP4_P1, 809009/R002.4.7.1671762-Re3100SP4_P1, 809010/R002.4.7.1671762-Re3100SP4_P1, 809011/R002.4.7.1671762-Re3100SP4_P1, 809012/R002.4.7.1671762-Re3100SP4_P1, 809013/R002.4.7.1671762-Re3100SP4_P1, 809014/R002.7.4.1810621-Re |
|---|
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
- 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 - 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-3282-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.