FDA: Class I recall of HeartStart MRx Defibrillator

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.

Posted 02/09/2018] AUDIENCE: Emergency Medicine, Risk Manager, Nursing ISSUE: Philips is recalling the HeartStart MRx Defibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected.

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