MRI scanner user interface defect may cause incorrectly oriented images
GE Healthcare recalls SIGNA Premier MRI scanners (100 devices, worldwide distribution) due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of Save RX, potentially resulting in incorrectly annotated or flipped diagnostic images.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is diagnostic accuracy risk from misoriented or misannotated patient images due to a user interface button-proximity defect.
Plain-English summary
GE Healthcare has issued a recall of 100 SIGNA Premier whole-body magnetic resonance (MRI) scanners distributed worldwide. These devices contain a user interface defect in the scan preparation workflow.
The "Patient Orientation" button and the "Save RX" button are positioned such that the Patient Orientation button may be inadvertently clicked when an operator intends to click Save RX. When this occurs, the prescribed patient orientation is changed prior to the initial 3-Plane Localizer Scan. Selecting and saving a patient orientation that does not match the patient's actual physical position may result in diagnostic images that are incorrectly annotated or flipped.
No illnesses or injuries have been reported in association with this recall.
The recalled product
- Product
- SIGNA Premier - 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
- image-annotation-error
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)
- Not Available
Distribution
Distribution scope not specified by the agency.
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