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FDA issues safety communication for HeartStart AEDs

On Nov. 25, the U.S. Food and Drug Administration (FDA) issued a safety communication stating that certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Read more.

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