Recall of Thousands of MRI Scanners Issued by US FDA

The United States (US) Food and Drug Administration (FDA) has issued a Class 1 Recall notice for a large number of GE Healthcare (Chalfont St. Giles, Buckinghamshire, UK) Magnetic Resonance Imaging (MRI) systems. All MRI systems using superconducting magnets, manufactured from 1985 to the present are affected. The notice was dated February 18th, 2015.

Already on January 6, 2015, GE Healthcare had sent an "Urgent Medical Device Correction" letter to hospital administrators/risk managers, radiology department managers, and radiologists, in the US and around the world. The letter described the safety issue, safety instructions, affected product details, product correction and contact information. The letter was necessary when GE Healthcare discovered that the Magnet Rundown Units (MRU) on its imaging devices may not be properly connected.

To correct the issue, GE Healthcare has instructed customers to perform preventative measures to confirm that the MRU is connected to the magnet. The measures consist of a four-step test on the MRU. The steps are explained on the GE Healthcare and FDA websites.

According the FDA recall notice, “In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries.”

Related Links:
GE Healthcare
US Food and Drug Administration (FDA)