‘Human error’ related to emergency shut off led to GE MRI recall notice

A recent FDA Class 1 recall notice affecting thousands of GE Healthcare MRI systems was related to a “single safety incident” in India in which the magnetic rundown unit (MRU) of a system was disconnected, according to GE Healthcare.

“This U.S. FDA notice was not related to any manufacturing defect or product-related error. It was a case of human error on site,” a GE spokesman said in an email to Health Imaging.

The MRU is essentially an emergency shut off switch for an MRI system’s superconducting magnet, which can be engaged should a ferrous object need to be removed from the magnet. GE Healthcare recommends the MRU be checked weekly.

In January, GE Healthcare sent users a letter describing the issue and the process for testing the MRU, and earlier this month, the company issued a voluntary field corrective action. GE Healthcare field service engineers also are in the process of inspecting MRI systems globally at no charge regardless of whether the site has a GE service contract in effect, according to the company.

In the January letter, GE Healthcare described the four-step MRU test as follows:

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 in 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 does not perform as described in any of these steps, customers were asked to stop using the system and contact a service representative.