United Imaging uMI Panorama GS PET/CT Systems Recalled for Software Defect
Shanghai United Imaging Healthcare is recalling three uMI Panorama GS 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 does not report any injuries, illnesses, or hospitalizations. The hazard is limited to a software defect that may require rescans, fitting the criteria for a moderate severity score.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling three units of the Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software. The recall involves specific serial numbers and UDI-DI codes distributed across multiple U.S. states and Puerto Rico.
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, which may result in the need for rescans.
Healthcare facilities that have purchased or received these specific systems should contact the manufacturer for further instructions regarding the software issue.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS 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: 06971576832187. Serial Number: 11MIP00007/R001.17.5.1785268
- 11MIP00009/R001.18.2.1967222
- 11MIP00010/R001.18.2.1967222
Distribution
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