FDA Issues Class 1 Recall for 13,000 GE Healthcare MRI Systems

The FDA placed a Class 1 recall on some MRI systems from GE Healthcare. The recall, which was spurred by employee errors rather than equipment failures, affects almost 13,000 devices.

According to the FDA, GE sent letters to customers on Jan. 6 detailing concerns about certain MRI systems with superconducting magnets. On Feb. 4, GE announced a voluntary field corrective action. It wrote that “some MR systems in India have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit.”

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