The U.S. Food and Drug Administration (FDA) has ordered a recall of thousands of MRI scanners manufactured by GE Healthcare to correct a problem that could "result in life-threatening injuries" if magnet shutdown modules are disconnected, according to an FDA notice.
In the notice, dated February 18, the FDA announced that it has ordered a class I device recall of all GE MRI scanners using superconducting magnets. The recall covers some 33 brand names of scanners and thousands of systems distributed throughout the world, manufactured from 1985 to today.
The notice describes the problem as pertaining to the systems' magnet rundown units (MRUs), which are designed to initiate a controlled quench and turn off the magnetic field in the event of certain problems with the scanner, such as a ferromagnetic object introduced into the MRI suite. Such shutdowns are only intended for extreme emergencies and can put an MRI magnet out of commission for a week or more and cost up to $30,000 to replace lost helium, according to the website MRIQuestions.com.
In GE's case, a scanner's magnetic rundown unit may not actually be connected to the scanner, according to the FDA recall notice. In an emergency, a disconnected MRU "could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries," the notice said.
GE sent an "urgent medical device correction" letter to its affected customers on January 6, providing instructions for confirming that the MRU is connected to the magnet. The test involves a four-step process for ensuring the MRU is in operation and has not been disconnected by any onsite personnel after installation; if the scanner fails the test, GE recommends that customers stop using the system and contact their GE representative. GE noted that the test is one that operator manuals advise users to perform on a regular basis and should take about five minutes.
The company said it learned of the problem after discovering that some MRI scanners in India had been modified by service personnel or by equipment users to disable the magnet rundown unit. In addition to alerting customers to the problem, GE noted that the red magnet rundown button should only be pressed in an emergency situation.
GE also pointed out that the FDA notice was not related to any manufacturing defect or product-related error, and, in fact, it was a case of human error onsite and is related to a single safety incident in India. GE wanted to ensure that such human error was not occurring at other sites globally.
"Maintaining a high level of safety and quality is GE Healthcare's highest priority," a GE spokesperson told AuntMinnie.com in an email. "GE Healthcare will be deploying service engineers to address any customer concerns as quickly as possible."
GE is fielding questions about the recall at 800-437-1171 or 262-513-4122.
