medical Class II Updated 2021-07-21

GE Healthcare, LLC recalls Discovery MR750 3.0T - Product Usage: is a whole body magnet

Recalled Product

Discovery MR750 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.


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

Distribution: Worldwide distributions.
View official government recall

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