United Imaging uMI Panvivo PET/CT Systems Recalled for Software Defect
Shanghai United Imaging Healthcare is recalling three uMI Panvivo PET/CT systems due to a software issue 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, but the source text explicitly states no injuries or illnesses have been reported, and the hazard is limited to the need for rescans rather than direct physical harm.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling three units of the Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software. 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 defect prevents patient images from being visible on the Patient Administration interface.
The affected systems are distributed nationwide in the United States, specifically 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, SC, WI, IL, MS, MA, and NJ. The specific serial numbers and software versions affected are 11MI500004/R002.4.0.1872339, 11MI500005/R002.4.0.1872339, and 11MI500006/R002.4.0.1872339.
The primary consequence of this software defect is that patient images may not be visible, which may result in the need for rescans. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 3
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 (3)
- UDI-DI: 06971576832231. Serial Number/Software: 11MI500004/R002.4.0.1872339
- 11MI500005/R002.4.0.1872339
- 11MI500006/R002.4.0.1872339
Distribution
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