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FDA Issues Warning over Philips Defibrillators

Destiny Baker3 years ago

The U.S. Food and Drug Administration has issued a warning over previously recalled automated external defibrillators manufactured by Philips Medical Systems stating that the devices may be unable to deliver life-saving shocks.

About the FDA Warning

According to Reuters, Philips issued a voluntary recall for the HeartStart AEDs in August 2012 after receiving reports that an internal flaw may prevent the devices from delivering an electric charge that jolts the heart back into a normal rhythm.

The FDA declared a class II recall the following month after determining that the defect could result in severe adverse events or death.

However, many of the defective defibrillators remain in schools, shopping malls, medical offices and private homes for use by first responders in case of an emergency.

The FDA is now urging that consumer and first responders contact Philips to have these defective units replaced immediately.

Detail of the Original Philips HeartStart Recall

  • The 2012 recall affected over 600,000 devices worldwide. About half were located in the United States.
  • Defective units were manufactured between 2005 and 2012.
  • Brand names included:

    • HeartStartFRx
    • HeartStartHome
    • HeartStartOnsite
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