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.
This issue is separate from the Company’s November 13 announcement regarding a voluntary medical device correction. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site at https://www.cardiacscience.com/AED1951.
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:
o Powerheart 9300A, 9300E, 9300P, 9390A, 9390E
o CardioVive 92532
o CardioLife 9200G and 9231
Customers who received any of these AED models since October 19, 2009 can visit https://www.cardiacscience.com/AED1952 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.
All affected AEDs will be replaced at no charge to the customer. Cardiac Science will contact customers by letter and will provide them with replacement AEDs as soon as they are available. Replacement shipments are anticipated to begin February 15.
The Company expects to record a charge of between $2.0 and $3.0 million in the fourth quarter of 2009, reflecting its current estimate of the expected costs relating to this action. Actual costs may vary based on a variety of factors. Cash expenditures relating to replacement of the affected AEDs will occur in the first half of 2010. The company does not currently believe this action will have a significant adverse impact on its ability to fulfill AED orders for the first quarter.
Customers may contact the Company immediately at 888.402.2484 within the United States. Outside the US, customers can contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at [email protected] for more information.