United Imaging uMI 780 PET/CT System Software Recall
Shanghai United Imaging Healthcare is recalling one uMI 780 PET/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 involves a software defect that may result in the need for rescans, which is a moderate operational issue without reported serious injuries or deaths.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling one unit of the Positron Emission Tomography and Computed Tomography System, Model: uMI 780. The recall is due to a software problem that occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study.
This software defect prevents patient images from being visible on the Patient Administration interface. As a result, the issue may lead to the need for rescans for affected patients. The affected unit is identified by UDI-DI 06971576832033 and Serial Number/Software 300098/R001.19.0.1812568.
The device was distributed in the United States, including 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, SC, WI, IL, MS, MA, and NJ. Healthcare facilities should contact the manufacturer for instructions on how to resolve the software issue.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI 780
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 1
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 (1)
- UDI-DI: 06971576832033. Serial Number/Software: 300098/R001. 19.0.1812568
Distribution
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