GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a user interface error that creates a risk of diagnostic error through incorrect image annotation or orientation. Although no patient injuries or illnesses have been reported, the potential for diagnostic error in medical imaging justifies a High severity rating.
Plain-English summary
GE Healthcare has recalled 248 units of the Discovery MR750 3.0T magnetic resonance scanner due to a user interface error. The issue occurs when the Patient Orientation button may be inadvertently clicked instead of the Save RX button on the system controls.
When the Patient Orientation button is pressed unintentionally, it changes the prescribed patient orientation on the system before running the initial 3-Plane Localizer Scan. This causes the scan to be performed with an orientation that does not match the patient's actual position during the procedure.
The consequence of this error is that the resulting images may be incorrectly annotated and/or flipped, which could affect the accuracy of diagnostic interpretation. The 248 affected units have been distributed worldwide to medical institutions using this scanner.
The recalled product
- Product
- Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- ui-error
- imaging-error
- diagnostic-error-risk
Distribution
Distribution scope not specified by the agency.
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