Medical Device Safety and Recalls: GE Healthcare Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 25 Feb 2015 12:09:00 -0600

Title:     Medical Device Safety and Recalls: GE Healthcare Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit

  A recall has been issued for the GE Healthcare Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit.   Some MRI units may have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit (MRU).
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 such 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.
The use of affected product may cause serious adverse health consequences, including death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm435537.htm

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