GE Revolution CT scanner user interface fails to confirm scan group names
The GE Revolution CT imaging system's user interface fails to update and confirm when scan group names contain characters other than letters, numbers, or spaces, potentially causing user uncertainty during scan setup.
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: This is an FDA Class II recall for a software user interface functionality issue in a medical imaging device. The issue prevents proper confirmation of scan group additions but does not report any patient injuries or illnesses, qualifying it as a moderate-risk voluntary recall.
Plain-English summary
The GE Revolution CT is a computed tomography imaging system manufactured by GE Healthcare and distributed in the United States. The system is intended to produce cross-sectional images of the body for diagnostic imaging applications.
The FDA has issued a Class II recall due to a user interface issue. When adding one or more scan group names containing characters other than letters, numbers (0-9), or spaces, the user interface will not update to confirm that the intended group(s) has been added to the acquisition.
This limitation affects the system's ability to provide visual confirmation of scan group creation to operators. Users may be uncertain whether their scan group additions were successful when using invalid character combinations.
Healthcare facilities operating GE Revolution CT systems should be aware of this issue and take appropriate precautions when adding scan group names to ensure proper device operation.
The recalled product
- Product
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either witho
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — CT Scanner
- Hazard
- ui-malfunction
- status-confirmation-failure
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)
- Revolution CT
Distribution
Distribution scope not specified by the agency.
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