Cardiac Science has initiated 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, according to the Bothell, Wash.-based company, which added that it informed the FDA of the situation.
Cardiac Science reported it detected the current complication 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 Oct. 19, 2009, and Jan. 15, 2010, and include the following models:
- Powerheart 9300A, 9300E, 9300P, 9390A, 9390E;
- CardioVive 92532; and
- CardioLife 9200G and 9231.
The company also said that this recall is separate from the FDA warning issued in November 2009 about the possibility of malfunction during the use of Powerheart and CardioVive AED G3 series, manufactured between August 2003 and August 2009.
Anyone who received any of these AED models since October 19, 2009 can visit http://www.cardiacscience.com/AED195 to determine if they have an affected AED. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.