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GE MRI’s recalled by FDA, WHAT YOU SHOULD DO.

Posted by Vikki Harmonay on Mon, Mar 2, 2015 @ 11:03 AM

On February 18th, 2015 General Electric announced a recall that may include your GE MRI system.  This “field corrective action” covers it total install base of 12,968 MRI systems installed worldwide. GEMRIRecall

The recall directly says: In certain locations, the MRU (magnetic rundown unit) may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.”

This is a problem from poor training or employee mistakes.  The problem was not caused by an equipment malfunction.

GE first became aware of the problem from an incident in India at the end of 2014. The company notified its customers of the issues and instructed them to conduct a five-minute test to ensure the MRU is connected to the magnet.

General Electric has instructed customers to do the following:  As a preventative measure, confirm that the MRU is connected to the magnet by performing the following four step test on the MRU. 

  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.   If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning.  
  4. Place the TEST HEATER toggle switch to the B position  Green HEATER TEST LED should light.   If it does not light, depress TEST HEATER LED switch to verify that the LED is functioning. 

If the MRU test does not perform as described in each of the 4 steps above, General Electric STRONGLY recommends that you stop using the system, and immediately call for service.

Please remember that this is not a manufacturing flaw, but a user issue that General Electric thought was serious enough to ensure that was not occurring with their MRI systems.

For more information go to FDA Site by clicking here!

Contact Atlantis Worldwide for your MRI needs.  Call Aston Diaz at 212-366-9100 or astondiaz@atlantisworldwide.com

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Topics: Used Medical Imaging Equipment, MRI