MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare's Discovery MR450 1.5T MRI system may inadvertently change patient orientation when users click the wrong button, resulting in flipped or incorrectly annotated images that could affect diagnostic accuracy.
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 a Class II medical device recall involving a user interface design issue that may result in flipped or misoriented diagnostic images. Although no patient injuries have been reported, the potential for diagnostic error due to incorrect image orientation constitutes a risk-of-harm scenario warranting High severity.
Plain-English summary
GE Healthcare is recalling the Discovery MR450 1.5T Nuclear Magnetic Resonance Imaging System due to a user interface issue. The 'Patient Orientation' button is positioned close to the 'Save RX' button, and users may inadvertently click the wrong button when attempting to save prescription information.
When the Patient Orientation button is clicked unintentionally, it changes the prescribed patient orientation setting prior to running the initial 3-Plane Localizer Scan. This can result in images that are incorrectly annotated or flipped, potentially affecting the accuracy of diagnostic interpretation.
Approximately 40 units have been distributed worldwide. Healthcare facilities using this device should be aware of this potential issue. Users should exercise caution when clicking near the Save RX button to ensure the correct button is selected before running scans. Contact GE Healthcare for guidance on device updates or remediation steps.
The recalled product
- Product
- Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- image-flipping
Distribution
Distribution scope not specified by the agency.
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