A Class I recall has been issued for more than 12,000 MRI systems manufactured by General Electric, Modern Healthcare reports. The recall was issued because of a potentially life-threatening problem that can occur when parts are not connected properly. Many GE MRI brands, including Signa and Discovery, are affected by the recall.
Class I recalls are the FDA’s most serious recall status, and are reserved for situations where serious injury or death can occur. In this case, the problem was that the magnet rundown units may not be connected properly. “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the FDA said in its recall notice, issued Feb. 18. The recall affects a total of 12,968 machines; 5,708 are in the United States and the rest are in other countries.
The problem is attributed to poor training or employee error. “Some MR systems in India had been modified to disable the magnet rundown unit,” a GE spokeswoman said, according to Modern Healthcare. “This did not happen during manufacturing.”
In January, GE sent letters to customers alerting them to the problem. Customers were urged to make sure the MRU is properly connected through a four-part test.