Earlier this month, GE Healthcare recalled 12,968 MRI systems due to a disabled Magnet Rundown Unit (MRU) in India. When this unit is disabled, it can slow the removal of a magnetic object from the scanner. This can lead to life-threatening consequences, prompting a Class I recall.
Class I recalls are reserved for issues that can lead to serious injuries or death. They are the U.S. Food and Drug Administration’s (FDA’s) most serious type of recall.
According to DOTmed Daily News, GE learned of the MRU being disabled in India at the end of 2014. Customers were notified of the issue and were instructed to perform a five-minute test to ensure that the MRU is properly connected to the rest of the system. The test begins with verifying that the green charger power LED is lit. Then, the user must depress and hold the test battery switch for 15 seconds. While the switch is being depressed, the green battery test LED should be lit. The next step is to put the test heater toggle switch in the “A” position and ensure that the test LED lights up. Lastly, the user needs to ensure that the test LED is lit when the toggle switch is moved to the “B” position.
If the test fails, GE “strongly recommends” to not use the MRI system and to immediately contact your GEHC representative. DOTmed Daily News reports that a GE field engineer will dispatched to every site to check that the test was performed; a follow-up test will also be conducted.
The recall affects 5,708 systems in the United States and includes many GE MRI brands, including Signa and Discovery.