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:
- Powerheart 9300A, 9300E, 9300P, 9390A, 9390E
- CardioVive 92532
- CardioLife 9200G and 9231
For more information, go to http://www.fda.gov/Safety/Recalls/UCM200123
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