SIGNA MR380 MRI System Patient Orientation Button May Click Unintentionally
GE Healthcare is recalling the SIGNA MR380 MRI system due to a user interface flaw where the Patient Orientation button may be inadvertently clicked instead of the Save RX button. This can result in incorrectly annotated or flipped MRI images.
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: FDA Class II recall with no reported hospitalizations, injuries, or illnesses. The hazard is a user interface design flaw that can result in image orientation errors affecting diagnostic accuracy, but represents a precautionary recall rather than a directly documented safety threat.
Plain-English summary
GE Healthcare is recalling the SIGNA MR380 Nuclear Magnetic Resonance Imaging System due to a user interface design flaw. The Patient Orientation button may be inadvertently clicked when users intend to click the Save RX button.
When the Patient Orientation button is unintentionally activated, the system changes the prescribed patient orientation before the initial 3-Plane Localizer Scan is run. If a patient orientation that does not match the patient's actual position is selected and saved, the resulting MRI images may be incorrectly annotated or flipped, which could affect the accuracy of diagnostic interpretation.
The SIGNA MR380 system has been distributed worldwide. GE Healthcare has identified this issue and initiated a recall. Healthcare facilities using this equipment should contact the manufacturer for corrective action guidance.
The recalled product
- Product
- SIGNA MR380, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI System
- Hazard
- image-orientation-error
- incorrect-annotation
Distribution
Distribution scope not specified by the agency.
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