Citing issues with how the magnetic rundown unit (MRU) is connected to the magnet at some MRI sites, the Food and Drug Administration (FDA) has issued a Class 1 recall for all GE Healthcare MRIs with superconducting magnets, and GE Healthcare is asking its customers to perform a test to ensure that the MRU is properly connected.
The recall covers 25 different MRI systems, and affects 12,968 units worldwide (5,708 in the U.S. and 7,260 outside the U.S.). The FDA cited “employee error” as a cause for the action
According to Emanuel Kanal, MD, chair of the American Board of Magnetic Resonance Safety, and director, magnetic resonance services, and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center, the genesis of the recall can be traced back to an incident that occurred in India last November.
As reported in several Indian newspapers, two employees of Tata Memorial Hospital in Parel, Mumbai were injured when an MRI machine’s magnetic field pulled in an oxygen cylinder and pinned the two individuals against the machine. According to the reports, the two employees remained pinned against the machine for four hours when hospital employees were unsuccessful in their attempts to quench the magnet.
In its recall notice, the FDA reported that the reason for GE Healthcare’s action was that “at certain sites, the MRU (Magnetic Rundown 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.”
According to the FDA, GE Healthcare sent an “Urgent Medical Device Correction” letter dated January 6, 2015 to affected customers that described the safety issue and included affected product details and correction and contact information.
Customers were instructed—as a preventive measure—to perform a four-part test. If the test doesn’t perform as described in each of the four steps, GE Healthcare recommends that customers stop using the system and call their GE Healthcare representative.
“What [GE Healthcare] is essentially saying is that every site internationally needs to run a test to verify their emergency run-down unit is working,” said Kanal. “It’s a very simple five-minute procedure.”
Click here to see the FDA notice.