The U.S. Food and Drug Administration has issued a safety communication saying certain HeartStart automated external defibrillator devices made by Philips Medical Systems, a division of Philips Healthcare whose U.S. headquarters are in Andover, Mass., may not deliver the defibrillator shock in a cardiac emergency situation.
The HeartStart AEDs in question, HeartStart FRx, HeartStart HS1 Home and HeartStart HS1 OnSite, were manufactured between 2005 and 2012. Philips Healthcare previously recalled these AEDs in September 2012 due to a failing internal electrical component. On Nov. 19, 2013, Philips Healthcare issued a Medical Device Safety Notice saying the failure of the electrical component could cause the AED to fail to deliver an appropriate shock.
The FDA recommends healthcare providers using recalled HeartStart AEDs should keep them in service until getting new ones, as there is more of a benefit in attempting to use the AED than not using one at all.
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