Official recall notice
Computed Tomography X-ray System Recall (Oct 2026)
Product: Computed Tomography X-ray System, Model: uCT 550 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: 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