General Electric Recalls MRI Units for Safety ConcernsFeb 25, 2015
GE Healthcare initiated a "field corrective action" earlier this month on nearly 13,000 magnetic resonance imaging (MRI) units worldwide after discovering that the Magnet Rundown Unit (MRU) in India was disabled.
Disconnecting the MRU could delay the removal of a magnetic object from the MR, and this could have life-threatening consequences, DOTmed News reports. The FDA has classified this recall Class I, its most serious recall category, reserved for situations where use of the device could result in serious injury or death.
"That’s our entire install base and we’re doing that because all of our MRs have this emergency safety shutoff," Ben Fox, director of America's external relations at GE, told DOTmed News. Fox said it would be "irresponsible” to check just the units in India.
GE first became aware of the incident in India at the end of 2014. The company immediately instructed imaging facilities to conduct a five-minute test to ensure the MRU was connected to the magnet. If the unit does not perform correctly during the test, GE "strongly recommends" the customer not use the unit and immediately call a GE Healthcare representative. In addition to customer testing, the company said it will send a field engineer to every site to ensure that the test was conducted and to conduct a follow-up test at no cost, according to DOTmed News.
The FDA says 5,708 of the recalled MRI units are in the U.S. and 7,260 in other countries. A full listing of recalled models and serial numbers can be found in the recall announcement on the FDA web site.