United StatesWhat's being recalled
Computed Tomography X-ray System, Model: uCT 530 with software
Computed Tomography X-ray System, Model: uCT 550 with software
Computed Tomography X-ray System, Model: uCT 760 with software
Computed Tomography X-ray System, Model: uCT 780 with software
Computed Tomography X-ray System, Model: uCT ATLAS with software
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Recalling firm: Shanghai United Imaging Healthcare Co., Ltd., Shanghai, China.
How to identify it
UDI-DI: 06971576831012. Serial Numbers/Software: 300174/R001.19.5.1839204-Re3300SP1H1_P4, 304006/R001.17.6.1607336-Re3100SP4, 304007/R001.19.4.1810621-Re3300SP1H1_P3, 304008/R001.19.4.1810621-Re3300SP1H1_P3 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 UDI-DI: 06971576831043. Serial Number/Software: 600271/R003.8.4.1810621-Re3300SP1H1_P3 UDI-DI: 06971576831050. Serial Number/Software: 684001/R001.17.6.1607336-Re3100SP4, 684002/R001.17.6.1607336-Re3100SP4, 684003/R003.8.4.1810621-Re3300SP1H1_P3, 684004/R003.8.4.1810621-Re3300SP1H1_P3, 684005/R003.8.4.1810621-Re3300SP1H1_P3, 684006/R003.8.4.1810621-Re3300SP1H1_P3, 684007/R003.8.4.1810621-Re3300SP1H1_P3, 684008/R003.8.4.1810621-Re3300SP1H1_P3, 684009/R003.8.4.1810621-Re3300SP1H1_P3, 684010/R003.8.4.1810621-Re3300SP1H1_P3, 684011/R003.8.4.1810621-Re3300SP1H1_P3, 684012/R003.9.0.1776134-Re-3300SP2, 684013/R003.11.0.1897081-Re3310SP1, 684014/R003.11.0.1897081-Re3310SP1 UDI-DI: 06971576831104. Serial Number/Software: 863001/R001.17.6.1607336-Re3100SP4, 863002/R001.17.6.1607336-Re3100SP4…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)