FDA announces recall of certain GE MRI systems

The Food and Drug Administration yesterday announced a Class I recall of all GE Healthcare Magnetic Resonance Imaging systems with superconducting magnets. According to the notice, there are 12,968 of the MRI systems, including 5,708 in the U.S. In a Feb. 4 announcement, GE Healthcare said it had initiated a “voluntary field corrective action” for all GE MR systems with superconducting magnets manufactured since 1985, because it found that some systems in India have been modified by service personnel or equipment users to disable the Magnet Rundown Unit. “In emergency situations, a disconnected Magnet Rundown Unit could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the company said. According to FDA, the company sent a Jan. 6 letter instructing customers to perform a four-part test to confirm that the MRU is connected to the magnet. If the MRU test does not perform as described in each of the 4 steps, the company “strongly recommends” that they stop using the system and immediately call their GE Healthcare representative, the FDA notice states. Those with questions about the recall may call 262-513-4122, the agency said.