February 28, 2019

FDA: Class I recall of Physio-Control LIFEPAK 15 Monitor/Defibrillator

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on February 27 identified the recall by Physio-Control, Inc (Redmond, Washington) of its LIFEPAK 15 Monitor/Defibrillator as Class I, the most serious.

The recall was initiated because the device may “lockup” (freeze) after a shock is delivered. Once it freezes, it cannot provide defibrillation therapy until it is reset by restarting it or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury, including death.

Distribution dates for the devices were March 21, 2013, to July 18, 2016.

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