GE Healthcare MRI Systems Recalled to Ensure Safety Feature Is Still Operational
February 25, 2015 | Risk Management News
The U.S. Food and Drug Administration has announced a class 1 recall of all nuclear magnetic resonance imaging (MRI) systems manufactured by GE Healthcare from 1985 to present. According to a February 4, 2015, voluntary field corrective action issued by GE Healthcare, the recall was initiated after the company found that some of its systems in India had been modified by service personnel or users to disable the magnet rundown unit—a critical feature used to disable the magnetic field in emergency situations. The manufacturer stresses the importance of having the magnetic rundown unit connected at all times, warning that "a disconnected magnet rundown unit could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries."