The U.S. Food and Drug Administration and General Electric are recalling more than 5,000 MRI systems in the U.S. and urging providers to do thorough testing.
Following GE’s disclosure to customers, the FDA has issued a class 1 recall for 12,968 of the company’s MRI systems out of concern for potentially life-threatening results from non-functioning part of the devices
GE discovered problems with the connections of the machine’s magnet rundown units, or MRUs, which also control the magnetic field that must be shut down in a patient emergency. The FDA recall covers 5,708 GE MRI machines under a variety of brands, including Signa and Discovery, in the U.S. and across more than 50 other countries.
In January, the company told customers of the problem and recommended that staff confirm that the MRU is connected to the magnet through a four step test involving the charger, battery and test heater. If at any step the MRU wasn’t working, GE said the facilities should stop using the machine and contact company representatives.
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While no incidents of patient harm have been reported, the FDA gave the recall its most urgent classification because of the possibility of a high-risk event.
“At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries,” The FDA said in its notice. “The MRU must be connected to the magnet at all times.”