The FDA has issued a Class I recall on more than 12,000 General Electric MRI systems because of a potentially life-threatening situation that can result when a part on the devices is not connected properly.
Class I is the FDA's most serious designation for recalls, indicating severe injury or death could occur as the result of issues with a product.
The recall covers numerous GE MRI brands, including Signa and Discovery. The 12,968 devices affected by the recall include 5,708 in the U.S. and 7,260 in other countries.
GE had discovered that the magnet rundown units on its imaging devices may not be properly connected.
“In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” the FDA says in its Feb. 18 recall notice.
The notice implores customers to perform a test to confirm that the MRU is functioning properly and has not been disabled. If it is not functioning properly, they are to stop using it.
The notice credits poor training or employee error for the issue. “Some MR systems in India had been modified to disable the magnet rundown unit,” a GE spokeswoman said. “This did not happen during manufacturing.”
GE sent letters to its customers in January urging them to ensure that the MRU is connected properly by performing a four-part test.
A request for comment from the American Hospital Association was not immediately returned. Representatives from both the Medical Imaging & Technology Alliance and the American College of Radiology, a trade group of diagnostic and interventional radiologists, radiation oncologists, nuclear medicine physicians and medical physicists, declined to comment on the recall.
Follow Virgil Dickson on Twitter: @MHVDickson