Life-threatening Issue Prompts Recall of General Electric MRI SystemsFeb 23, 2015
The Food and Drug Administration (FDA) has announced a Class I recall for more than 12,000 General Electric magnetic resonance imaging (MRI) systems. A potentially life-threatening situation can arise when a part on the imaging device is not connected properly.
The recall covers GE MRI brands including Signa and Discovery. The 12,968 devices affected by the recall include 5,708 in the U.S. and 7,260 in other countries, Modern Healthcare reports. GE had discovered that the magnet rundown units on its imaging devices may not be properly connected. "In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries," according to the recall notice. A full listing of models and serial numbers can be found in the announcement on the FDA web site.
A Class I recall is the FDA's most serious designation, reserved for situations where use of the device could result in serious injury or death. The notice urges customers to perform a test to confirm that the MRU is functioning properly and has not been disabled. If the unit is not functioning properly, the customer should stop using it.
A GE spokeswoman said some MRI systems in India "had been modified to disable the magnet rundown unit," but this "did not happen during manufacturing." In January GE sent letters to customers urging them to ensure that the MRU is connected properly by performing a four-part test.