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FDA issues reminder on Philips AED recall

December 9, 2013

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Washington – The Food and Drug Administration on Dec. 3 issued an alert regarding certain automated external defibrillator devices made by Philips Medical Systems. The alert offers recommendations for inspecting and monitoring the devices, as well as using them during an emergency.

Philips issued a voluntary recall of some devices in September 2012 because of an electrical malfunction that could cause the AED to incorrectly indicate it was ready for use. The recall was followed by a Medical Device Safety Notice in November 2013 warning that the malfunction could cause the device not to deliver a shock. The notice also referenced a maintenance advisory for the devices.

The devices were distributed between 2005 and 2012 and have the following names:

  • HeartStart FRx
  • HeartStart HS1 Home
  • HeartStart HS1 OnSite