The U.S. Food and Drug Administration has issued a Class I recall of nearly 13,000 GE Healthcare MRI systems with superconducting magnets, not because of a product deficiency, but because of an employee error.
GE Healthcare found that some units in India were modified by service personnel or equipment users to disable the magnet rundown unit, which is used to shut off the magnetic field of the system in an emergency situation. According to the FDA recall, this can delay removal of ferrous objects from the magnet in emergency situations, which can possibly lead to life-threatening injuries.
"The MRU must be connected to the magnet at all times," the recall reads.
In addition to the recall, issued Feb. 18, GE Healthcare sent an "Urgent Medical Device Correction Letter" Jan. 6 to affected organizations, which described the issue and how to correct it.
A Class I recall is issued by the FDA in "a situation in which there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."