The Food and Drug Administration (FDA) is warning emergency medical professionals, health care professionals and consumers about a recall of Powerheart, Cardiovive, CardioLife models of Cardiac Science Automated External Defibrillators (AED) because the devices may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. Cardiac Science Corporation says the AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. About 12,200 devices are affected by the recall.

The recall comes on the heels of a November 13, 2009, recall of Cardiac Science AEDs for the addition of a correction device. The two recalls are for separate issues, the company reports. An internal quality review by Cardiac Science detected the issue. To date, the company has received no reports of the problem nor any complaints on the product by consumers.

The affected AEDs were manufactured or serviced between October 19, 2009, and January 15, 2010, and include the Powerheart 9300E, 9300P, 9390A and 9390E; CardioVive 92532; and the CardioLife 9200G and 9231. Consumers can visit www.Cardiascience.com/AED195 to determine if their AED is affected by the recall. Affected devices should be removed from service immediately. Cardiac Science will replace the AEDs at no charge to the customer.

U.S. customers with questions regarding the recalled AEDs may contact Cardio Science at 888-402-2484. International customers can contact the company at +44-161-926-0011. Customers can also e-mail the company at aed195@cardiacscience.com. Any adverse events associated with this or any other medical device should be reported to the FDA’s MedWatch Adverse Events Reporting System at www.fda.gov/Medwatch.