The FDA says that all GE Healthcare MRIs with superconducting magnets are potentially deadly by requiring a recall of nearly 13,000 of the imaging systems saying there is a reasonable probability that the device “will cause serious adverse health consequences or death.”The recall covers 25 different MRIs, including several versions of the Signa brand and three versions of the Discovery brand. GE is recalling over 10,000 MRI machines.
“At certain sites, the MRU (magnetic resonance unit) may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times,” the recall notice says.
The FDA says GE sent customers a letter in January urging them to ensure that the MRU is connected to the magnet by performing a four-part test. The test is detailed in the FDA’s recall notice.
The FDA says 12,968 devices are affected including 7,260 outside the U.S. in several countries from Albania to Zambia.
Jeffrey Newman represents whistleblowers.