FDA safety communication advises of potential malfunction in Philips defibrillators

The U.S. Food and Drug Administration has issued a new safety communication for previously recalled HeartStart automated external defibrillator devices, advising that some of the AEDs may be unable to properly perform in cardiac emergencies.
            
Philips Healthcare initiated a Voluntary Medical Device Recall of approximately 700,000 HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs in September 2012. The recall came after a determination that an internal electrical component in the AEDs could fail and the devices could incorrectly indicate readiness for use.
            
Philips Healthcare also issued a Medical Device Safety Notice dated Nov. 19, 2013, providing customers with updated information about the failure of an electrical component that could cause the AEDs to fail to deliver appropriate shock.   

 

READ MORE: FDA safety communication advises of potential malfunction in Philips defibrillators – American Dental Association – ADA.org.

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