FDA issues Class 1 recall for 13,000 MRI systems

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The FDA placed a Class 1 recall on some MRI systems from GE Healthcare. The recall, which was spurred by employee errors rather than equipment failures, affects almost 13,000 devices.

According to the FDA, GE sent letters to customers on Jan. 6 detailing concerns about certain MRI systems with superconducting magnets. On Feb. 4, GE announced a voluntary field corrective action. It wrote that “some MR systems in India have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit.”

The unit allows the magnetic field to be shut off in an emergency. "In emergency situations, a disconnected Magnet Rundown Unit could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries," according to the Feb. 4 announcement. "The Magnet Rundown Unit must be connected to the magnet at all times." 

Healthcare systems with MRIs were instructed to confirm that the magnet rundown unit was connected by following a list of steps. If at any step there was an indication that the unit wasn’t performing, they were instructed to stop using the imaging system and contact GE.

The recall affects 12,968 MRI systems worldwide.

The FDA wrote that the following devices include superconducting magnets: Discovery MR450; Discovery MR750; Signa HDx; Signa HDxt; Signa HDi; GE 1.5T Signa HDe; Optima MR360; Brivo MR355; Signa Excite-HD 1.5T & 3T; Signa Excite 1.5T HD Twinspeed; Signa Excite 1.5T HD Echospeed; Signa Excite 1.5T HD Highspeed; 1.5T Signa Infinity TwinSpeed; 1.5T Signa Infinity EchoSpeed Plus; 1.5T Signa Infinity HiSpeed Plus; 1.0T Signa Infinity HiSpeed Plus.; 1.0T Signa Infinity SmartSpeed; Signa EXCITE 3.0T; Signa EXCITE 3.0T HD; Signa Excite 1.5T TwinSpeed; Signa Excite 1.5T EchoSpeed; Signa Excite 1.5T HiSpeed; Signa Excite 1.5T SmartSpeed; Signa Excite 1.5T; Signa Excite 3.0T; Signa Contour/I; Signa OpenSpeed; Vectra; MR Max, Optima MR450w GEM; Discovery MR750W GEM; and Optima MR450w.