A potentially life-threatening issue has prompted GE Healthcare to recall 12,968 MRI systems. According to DOTmed Daily News, the recall was issued because a Magnet Rundown Unit (MRU) was disabled in India, resulting in a delay when removing a magnetic object from the system. The recall affects 5,708 systems in the United States and includes many GE MRI brands, including Signa and Discovery.
A Class I recall was issued for the systems. Recalls are designated as Class I when there is a reasonable risk of serious injury or death; it is the U.S. Food and Drug Administration’s (FDA’s) most serious recall status.
GE learned of the MRU being disabled in India at the end of 2014, DOTmed Daily News reports. Customers were alerted to the issue and told to perform a five-minute test to make sure that the MRU is properly connected.
To start the test, users are instructed to verify that the green charger power LED is lit. The next step is to depress and hold the test battery switch for 15 seconds and see that the green battery test LED is lit while the switch is depressed. Then, the user should put the test heater toggle switch in the “A” position and check to see that the test LED lights up. The last step is to move the toggle switch into the “B” position and ensure that the LED is lit.
GE “strongly recommends” to not use the MRI system if the test does not follow accordingly. Users should immediately contact their GEHC representative if this happens. DOTmed Daily News reports that a GE field engineer will dispatched to every site to check that the test was performed and also perform a follow-up test.