SIGNA Artist MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.
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 of a medical imaging system with no reported illnesses or injuries. The defect creates a risk of diagnostic error through image misorientation and incorrect annotation, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling 562 SIGNA Artist Nuclear Magnetic Resonance Imaging (MRI) systems that were distributed worldwide. The systems are affected by a user interface defect where button placement creates confusion between controls.
The Patient Orientation button and Save RX button are positioned in proximity on the system interface, which can result in the Patient Orientation button being inadvertently clicked when a user intends to click the Save RX button. When this occurs, the prescribed patient orientation is changed on the system prior to the initial 3-Plane Localizer Scan.
If patient orientation is changed to a setting that does not match the patient's actual position, the resulting images may be incorrectly annotated and/or flipped. This could result in misinterpretation of diagnostic imaging results.
The recalled product
- Product
- SIGNA Artist, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 562
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.
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