Some GE Healthcare MRI units, with superconducting magnets, may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The use of such modified MRI units may cause serious adverse health consequences, including death.
The MRU is one method used to shut off the magnetic field of the MRI in case of an emergency, such as when a metal (ferrous) object is brought into the magnetic field. In an emergency situation, a delay in shut off can potentially result in life-threatening injuries. There were two reported injuries when hospital employees entered the MRI room carrying a metal container.
MRI systems produce images of the internal structures of the body to aid health care providers in the diagnosis of health conditions. The primary users of this device are radiologists and technologists in hospitals and outpatient imaging centers.
This recall affects all GE Healthcare MRI systems with superconducting magnets manufactured and distributed from 1985 through December 2014. GE Healthcare sent an urgent medical device correction letter on January 6, 2015 to affected customers with instructions for confirming that the MRU is connected to the magnet.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, June 2012 Report: Too Much, Too Little, Too Late: Injuries from Delays and Failures to Perform CT Scans or Overexposure to Radiation