United Imaging uCT 760 CT System Recalled for Software Visibility Issue
Shanghai United Imaging Healthcare is recalling one uCT 760 CT system 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 hazard is a software defect causing image visibility issues and potential rescans, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling one unit of the Computed Tomography X-ray System, Model uCT 760, due to a software defect. The issue occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. In these specific conditions, patient images may not be visible on the Patient Administration interface.
The recall is limited to one unit with UDI-DI 06971576831043 and Serial Number/Software 600271/R003.8.4.1810621-Re3300SP1H1_P3. The affected system was distributed in the United States, including California, Puerto Rico, Utah, West Virginia, North Dakota, Nebraska, North Carolina, Texas, Idaho, Louisiana, Montana, Florida, Colorado, Indiana, Kentucky, Alabama, Ohio, Michigan, Iowa, Missouri, New York, Nevada, Tennessee, South Carolina, Wisconsin, Illinois, Mississippi, Massachusetts, and New Jersey.
The primary consequence of this software problem is that patient images may be invisible on the interface, which may result in the need for rescans. No injuries or illnesses have been reported in the source text. Healthcare facilities should contact the recalling firm for instructions on how to resolve the software issue.
The recalled product
- Product
- Computed Tomography X-ray System, Model: uCT 760 with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 1
Distribution
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