February 13, 2018

FDA: Class I recall of HeartStart MRx Defibrillator

By: Judy Mathias

Editor’s Note

The Food & Drug Administration (FDA) on February 9 classified the recall by Philips Electronics (Andover, Massachusetts) of its HeartStart MRx Defibrillator as Class I, the most serious.

The recall was initiated because of micro cracks in the gas discharge tube that allow internal gasses to escape and can cause the tube to malfunction.

The defects may also permit an electrical current surge to cross the device’s designated resistors, which will damage the resistors and prevent the device from working in automated external defibrillator mode. As a result, the defibrillator may fail at any time, including when delivering repeated shocks to patients.


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