February 3, 2010 - Bothell, WA – Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation. Cardiac Science detected this issue through its internal quality systems and has received no complaints or reports of this problem in the field. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models:
For more information, go to http://www.fda.gov/Safety/Recalls/UCM200123
Showing posts with label AED's. Show all posts
Showing posts with label AED's. Show all posts
Thursday, February 11, 2010
AED recall
Monday, September 15, 2008
AED Recall: LifePak CR Plus Automated External Defibrillators
[Posted by the FDA on 09/11/2008] Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service, or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
[September 11, 2008 - Full Recall Notice – FDA]
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