GE MR FDA recall over disabled Magnet Rundown Units GE MR FDA retira unidades de resonancia magnética desactivadas.
por Lauren Dubinsky, Senior Reporter | February 20, 2015
MRI
GE Healthcare initiated a "field corrective action" earlier this month on its 12,968 MR systems installed worldwide after they discovered that the Magnet Rundown Unit (MRU) on an MR in India was disabled. The FDA is classifying it as a class 1 recall.
Disconnecting the MRU has the potential to delay the removal of a magnetic object from the MR, which could have life-threatening consequences.
“That’s our entire install base and we’re doing that because all of our MRs have this emergency safety shutoff," Ben Fox, director of America's external relations at GE, told DOTmed News. "To just say that we’re just going to check the ones in India would be irresponsible."
GE first became aware of the incident in India at the end of 2014. The company immediately notified its customers of the issue and instructed them to conduct a five minute test to ensure the MRU is connected to the magnet.
To perform the test, the user must first verify that the green charger power LED is lit. Then they must depress and hold the test battery switch for 15 seconds. The green battery test LED should light up and remain lit while the test battery switch is depressed.
Next, the user has to place the test heater toggle switch in the “A” position and the green heater test LED should light. Finally, the test heater toggle switch should be moved to the “B” position and the green heater test LED should light.
If the MRU test does not perform accordingly, GE "strongly recommends" to not use the MR and to immediately call your GEHC representative.
In addition, a GE field engineer will be deployed to every site to ensure that the test was conducted and to conduct a follow-up test at no cost. "We do the follow-up with our field engineers in case, for some reason, the customer wasn’t compliant," said Amanda Gintoft, communications manager for MR at GE.
GE representatives stress that this is not a manufacturing flaw. "It’s not anything to do with the product, but it happened on a GE system and it was intentionally disconnected, so we thought it is serious enough to start a global scrub and make sure that other hospitals aren’t having the same situation," said Fox.
Disconnecting the MRU has the potential to delay the removal of a magnetic object from the MR, which could have life-threatening consequences.
“That’s our entire install base and we’re doing that because all of our MRs have this emergency safety shutoff," Ben Fox, director of America's external relations at GE, told DOTmed News. "To just say that we’re just going to check the ones in India would be irresponsible."
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To perform the test, the user must first verify that the green charger power LED is lit. Then they must depress and hold the test battery switch for 15 seconds. The green battery test LED should light up and remain lit while the test battery switch is depressed.
Next, the user has to place the test heater toggle switch in the “A” position and the green heater test LED should light. Finally, the test heater toggle switch should be moved to the “B” position and the green heater test LED should light.
If the MRU test does not perform accordingly, GE "strongly recommends" to not use the MR and to immediately call your GEHC representative.
In addition, a GE field engineer will be deployed to every site to ensure that the test was conducted and to conduct a follow-up test at no cost. "We do the follow-up with our field engineers in case, for some reason, the customer wasn’t compliant," said Amanda Gintoft, communications manager for MR at GE.
GE representatives stress that this is not a manufacturing flaw. "It’s not anything to do with the product, but it happened on a GE system and it was intentionally disconnected, so we thought it is serious enough to start a global scrub and make sure that other hospitals aren’t having the same situation," said Fox.
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