FDAJune 4, 2021device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

ge healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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