It is being reported through the FDA that some GE Healthcare MRI units, with super magnets, may have been altered by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU). The use of these MRI units may cause significant injuries, including death.
The MRU is one way used to shut of the magnetic field of the MRI in case of an emergency. Usually, in an emergency situation, a delay in shut off can result in life-threatening injuries. As of now, there have been two reported injuries when hospital employees entered the MRI room carrying a metal container.
As many of us know, 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. The recall affects 12,968 MRI systems worldwide, including more than 5,000 in the United States, after GE discovered problems with the MRU connection that controls the magnetic field and must be shut down in a patient emergency.GE Healthcare had told customers of the problem in January. The FDA recall was issued out of concern for potentially life-threatening results from a non-functioning part of the device.
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 consequence or death.
If you would like to read the FDA recall, click here: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435537.htm