Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit

[Posted 02/25/2015]

AUDIENCE: Radiology, Risk Manager, Biomedical Engineering

ISSUE: 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. See the FDA Recall Notice for additional infmation, including a product photo.

The use of affected product may cause serious adverse health consequences, including death.

BACKGROUND: GE Healthcare sent an urgent medical device correction letter (GEHC Ref# 60876) on January 6, 2015 to affected customers with instructions for confirming that the MRU is connected to the magnet.

RECOMMENDATION: 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, GEHC strongly recommends that you stop using the system, and immediately call your GEHC representative.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/25/2015 - Recall Notice - FDA]