Citing possible employee error in how the magnetic rundown unit (MRU) is connected at certain sites, the FDA issued a Class I recall for all GE Healthcare MRIs with superconducting magnets and the company is urging customers to properly test their equipment.
The recall covers 25 different MRIs, including those under the Signa, Discovery and Optima brands, and affects 12,968 installed systems (5,708 of which are located in the U.S.).
“At certain sites, the MRU 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,” read the recall notice. “The MRU must be connected to the magnet at all times.”
The FDA noted that last month, GE sent a letter to customers describing the issue and provided instructions on how to test that the MRU is properly connected.
The full list of affected systems and detailed preventative and testing procedures can be found here.