Official recall notice
Computed Tomography X-ray System Recall (Oct 2026)
Product: Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
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-Re3300SP1H1_P3, 809015/R002.7.4.1810621-Re3300SP1H1_P3, 809016/R002.9.0.1897081-Re3310SP1, 809017/R002.9.0.1897081-Re3310SP1, 809018/R002.7.4.1810621-Re3300SP1H1_P3, 809019/R002.7.4.1810621-Re3300SP1H1_P3, 809020/R002.9.0.1897081-Re3310SP1, 809021/R002.7.4.1810621-Re3300SP1H1_P3, 809022/R002.7.4.1810621-Re3300SP1H1_P3, 809023/R002.7.4.1810621-Re3300SP1H1_P3, 809024/R002.7.4.1810621-Re3300SP1H1_P3, 809025/R002.7.4.1810621-Re3300SP1H1_P3, 809026/R002.7.4.1810621-Re3300SP1H1_P3, 809027/R002.7.4.1810621-Re3300SP1H1_P3, 809028/R002.9.0.1897081-Re3310SP1, 809029/R002.7.4.1810621-Re3300SP1H1_P3, 809030/R002.7.4.1810621-Re3300SP1H1_P3, 809031/R002.7.4.1810621-Re3300SP1H1_P3, 809032/R002.7.4.1810621-Re3300SP1H1_P3, 809033/R002.9.0.1897081-Re3310SP1, 809034/R002.9.0.1897081-Re3310SP1, 809035/R002.9.0.1897081-Re3310SP1, 809036/R002.9.0.1897081-Re3310SP1, 809037/R002.9.0.1897081-Re3310SP1, 809038/R002.9.0.1897081-Re3310SP1, 809039/R002.9.0.1897081-Re3310SP1, 809040/R002.9.0.1897081-Re3310SP1, 809041/R002.9.0.1897081-Re3310SP1