MRI Scanner Patient Orientation Button Confusion Affects Images
GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall involves a user interface error with no reported illnesses or injuries, but poses a risk to diagnostic accuracy through potential image misorientation. The issue falls under the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The GE Healthcare Discovery MR750w 3.0T is a whole body magnetic resonance (MRI) scanner. A user interface issue has been identified where the "Patient Orientation" button may be unintentionally clicked when attempting to click the "Save RX" button on the system interface.
When this occurs, the patient orientation setting is changed before the initial 3-Plane Localizer Scan is performed. If the saved patient orientation does not match the patient's actual position, the resulting images may be incorrectly annotated and/or displayed in a flipped orientation.
The recall affects 585 devices distributed worldwide. GE Healthcare, the manufacturer, has initiated this recall to address the issue.
The recalled product
- Product
- Discovery MR750w 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
- Category
- Medical Device — MRI Scanner
- Affected units
- 585
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 14 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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