Recall Class: Class I
Date Recall Initiated: January 12, 2015
Manufacturing and distribution dates: 1985 to December 2014
Use: MRI systems produce images of the internal structures of the body to aid health care providers in the diagnosis of health conditions. The primary users of this device are radiologists and technologists in hospitals and outpatient imaging centers.
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Reason for Recall: 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.
The use of affected product may cause serious adverse health consequences, including death.
Public Contact: Questions about this recall should be directed to local service representatives or the GE Healthcare customer service line (24 hours a day, 7 days a week) at 1-800-437-1171.
FDA District: Minneapolis District Office
More Information about this Recall: 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. Customers with questions can contact their local GE Healthcare service representative or the GE Healthcare customer service line (24 hours a day, 7 days a week) at 1-800-437-1171.
The letter included the following safety instructions to confirm the MRU and magnet are connected:
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.
- Verify the green CHARGER POWER LED is lit.
- 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.
- Place the TEST HEATER toggle switch in the A position. The green HEATER TEST LED should light.
- 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.
Illustration of the MRU and Its Features:
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.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.