United Imaging uMI Panorama 35 PET/CT Systems Recalled for Software Defect
Shanghai United Imaging Healthcare is recalling seven uMI Panorama 35 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. The hazard is a software defect causing image visibility issues that may lead to rescans, but no injuries or illnesses have been reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling seven Positron Emission Tomography and Computed Tomography (PET/CT) systems, Model uMI Panorama 35, 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 covers seven units distributed across 30 U.S. states and Puerto Rico. The affected serial numbers are 11MI410003, 11MI410004, 11MI410005, 20MI410001, 20MI410002, 20MI410003, and 20MI410004, all associated with software version R001.19.4.1909524 or R001.21.0.1993334. The UDI-DI for the product is 06971576832170.
The primary risk associated with this defect is the potential need for patient rescans if images are not visible to the operator. No injuries or illnesses have been reported in connection with this recall. Healthcare facilities should contact the manufacturer for instructions on resolving the software issue.
The recalled product
- Product
- Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 7
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 (7)
- UDI-DI: 06971576832170. Serial Number: 11MI410003/R001.19.4.1909524
- 11MI410004/R001.19.4.1909524
- 11MI410005/R001.19.4.1909524
- 20MI410001/R001.19.4.1909524
- 20MI410002/R001.19.4.1909524
- 20MI410003/R001.21.0.1993334
- 20MI410004/R001.19.4.1909524
Distribution
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