On February 18, the FDA published a Class 1 recall of GE Healthcare MRI systems with superconducting magnets. The recall, which affects nearly 13,000 magnetic resonance imaging units, was prompted by an accident involving an MRI system in India after service personnel incorrectly disconnected the system’s magnetic rundown unit (MRU). The MRU, designed to act as an “emergency off switch” for the magnet, must be connected to the magnet at all times to maintain safety. A disconnection of the MRU can cause a delay in removal of a ferrous object from the magnet, which can lead to potentially life-threatening injuries.
In response to the Class 1 action by the FDA, GE Healthcare noted in a press release that the recall was not related to any manufacturing defect or product-related error, but was the result of a case of human error onsite, and is in response to a single safety incident in India. GE Healthcare indicated that the FDA and the company wanted to ensure this human error was not occurring at other sites globally.
According to news reports about the onsite incident in India, two employees of Tata Memorial Hospital in Mumbai were injured when an MRI machine’s magnetic field pulled in an oxygen cylinder and pinned the men against the machine for nearly four hours.
As a preventive measure, GE Healthcare is recommending that facilities with GE Healthcare MRI systems cease MRI operations until customers verify that, post-installation, no one has disconnected the MRU. The company recommends performing this check weekly at all sites. According to GE Healthcare, once proper MRU settings are confirmed, MRI operations can resume as normal.
Quoted in Radiology Business, Emanuel Kanal, MD, reiterated the importance of conducting the MRU check. Kanal is chair of the American Board of Magnetic Resonance Safety, director of magnetic resonance services, and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center. “What [GE Healthcare] is essentially saying is that every site internationally needs to run a test to verify their emergency run-down unit is working,” Kanal said. “It’s a very simple 5-minute procedure.”
The FDA noted that last month the American College of Radiology posted online a notification for customers from GE healthcare that described the issue and provided instructions on how to test that the MRU is properly connected. The FDA also provided a full list of affected systems and detailed preventative and testing procedures.