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FDA Issues GE MRI Machine Recall

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On February 18th, the FDA issued a recall of all GE MRI scanners with superconducting magnets. This includes 33 models in the GE line manufactured over the last 30 years. As a result of this order, thousands of units will need to be inspected and, potentially, corrected.

Check the recall notice on the FDA's website for a complete list of the models that are affected.

The Problem

The systems in question are under scrutiny due to the possibility of service personnel or users disabling the magnetic rundown unit, or MRU. An MRU is an emergency device that initiates a controlled magnet quench and shuts down an MRI machine's magnetic field. According to the FDA, "In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries." In other words, without the faster, simpler MRU shutdown available, a person could be trapped in or against an MRI machine for significantly longer while the site waits for one of the slower, more complicated shutdown procedures to be performed.

What You Need to Do

If your MRI system's model appears on the list, there's a test your on-site staff can perform to see if the MRU is connected properly. The steps are listed on the recall page near the bottom. According to a statement from GE reported at auntminnie.com, the test should only take about five minutes.

If your system does not pass the test, it is recommended you stop using it and call a GE Healthcare representative.