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The FDA has issued a Safety Commu­ni­cation headlined: “Heart­Start Automated External Defib­ril­lators (AED) From Philips Healthcare: Safety Commu­ni­cation — Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appro­priate Shock.”

There is a recall of 700,000 Philips Healthcare Automated External Defib­ril­lators (AEDs) because there is a possi­bility of failure in life or death situa­tions. Philips says that the AEDs may not be able to deliver life-saving shocks to people in emergency situa­tions due to an electronic malfunction.

The FDA provides this background: “An AED is a device that automat­i­cally analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly.”

The recalled models were sold between 2005 and 2012. and sold under the brand names Heart­StartFRx, Heart­StartHome and Heart­Star­tOnsite. According to the FDA, “The Philips Heart­Start FRx AED may be used by first responders including Emergency Medical Services (EMS) and fire depart­ments. The Philips Heart­Start HS1 Home AED may be used in the home. The Philips Heart­Start HS1 OnSite AED may be used in public locations including airports, community centers, schools and government buildings.”

To date, 61 devices have been repaired or replaced due to the problem, however there have been no reports of any patient being harmed as a result of this recall. Even though there is a recall, the FDA feels the benefits of attempting to use the AED in a cardiac arrest emergency to outweigh the risk of not attempting to use the AED.

For the complete FDA Recall Alert, click here.

FDA 12/3/13 News Release

Some defib­ril­lators may not deliver shock, FDA warns