GE Recalling MRI Systems Following Voluntary Corrective Action

GE Healthcare initiated a Class 1 recall of all MRI systems that have superconducting magnets, following a voluntary field corrective action. The recall affects nearly 13,000 devices manufactured since 1985.

The recall stems from a single safety incident in India that was the result of human error and not any manufacturing or product defect, GE said.

GE wrote in the field corrective action that some service personnel or equipment users in India modified the systems to disable the magnet rundown unit. The MRU is a method used to shut off the magnetic field of the MR system during an emergency. A disconnected MRU could delay removal of a metal object from the magnet, potentially resulting in life-threatening injuries; therefore it must be connected to the magnet at all times, GE said.

The devicemaker sent a letter to users instructing them to perform a short test to confirm the MRU is functioning properly and has not been disabled. The company will also send a service representative to inspect the systems.

To view the FDA’s recall notice, go to www.fdanews.com/02-25-15-GERecall.pdf. GE Healthcare’s Voluntary Field Corrective Action is at www.fdanews.com/02-25-15-GEVoluntary.pdf and a subsequent update is at www.fdanews.com/02-25-15-GEUpdate.pdf. — Kellen Owings