mri fda recall ge

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GE Healthcare sent an urgent medical device product recall correction letter to affected customers with instructions for confirming that the MRU is connected to the recalled magnet. 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 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.
As a preventative measure, please confirm that MRU is connected to the magnet by performing the following four step test on the MRU.

Important: Do not press the red RUNDOWN button located underneath the protective cover during this test. The RUNDOWN button is for Emergency Use only. Pressing this button will quench the magnet.

  1. Verify the green CHARGER POWER LED is lit.
  2. Depress and hold the TEST BATTERY switch for 15 seconds. The green BATTERY TEST LED should light and remain lit while the TEST BATTERY switch is depressed.
  3. Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light.
  4. Place the TEST HEATER toggle switch in the B position. Green HEATER TEST LED should light.

If the MRU test does not perform as described in each of the 4 steps above, with the specified LED lighting in each, GE Healthcare strongly recommends that you stop using the system, and immediately call your GEHC representative.

Please refer to your Safety Manual for precautions regarding handling metal around high magnetic fields. Not following these precautions can potentially result in life threatening injuries. Ensure that you are familiar with the routine inspection and maintenance of the system’s safety features, and with the multiple methods that can be used if an emergency quench of the magnetic field is required. All of these are documented in the Safety Manual provided with your MRI system.

About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

About the FDA
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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