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Philips AED recall
Philips AED recall
12/18/2013
FDA
NEWS RELEASE
FDA issues safety communication on HeartStart automated external defibrillators from Philips Healthcare
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation.
“If the device indicates it has detected an error during a self-test the FDA advises users to keep recalled HeartStart AEDs in service until a replacement from Philips Healthcare or another AED manufacturer is obtained,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator.”
These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Users of the recalled devices, who may include consumers and first responders, should contact
Philips Healthcare
for more information.
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