GE Healthcare, LLC recalls Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging Syste
Recalled Product
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Hazard / Issue
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
Issued by
FDA
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