United Imaging uCT 780 CT System Recalled for Software Visibility Issue
Shanghai United Imaging Healthcare is recalling 14 uCT 780 CT systems due to a software defect that may hide patient images, potentially requiring rescans.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or deaths, and the primary consequence is the need for rescans, which aligns with the criteria for a moderate severity recall involving low-risk operational issues.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling 14 Computed Tomography X-ray Systems, Model uCT 780, due to a software problem. The recall covers systems distributed nationwide in the United States, including specific states such as California, Texas, and New York.
The software issue occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. This defect prevents patient images from being visible on the Patient Administration interface. As a result, healthcare providers may need to perform rescans of patients.
Healthcare facilities should contact Shanghai United Imaging Healthcare for instructions on how to resolve the software issue. The recall is classified as FDA Class II.
The recalled product
- Product
- Computed Tomography X-ray System, Model: uCT 780 with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution
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