Service Announcements & Upgrades
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
Models Affected: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, and the CardioLife 9200G and 9231.
Full Description:Cardiac Science is conducting 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.
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 Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, Cardiovive 92532, and the CardioLife 9200G and 9231.
Customers who received an AED manufactured between October 19, 2009 and January 15, 2010 can contact us at 888.402.2484 within the United States. Outside the US customers can contact us at +44.161.926.0011. Each affected AED should immediately be removed from service since it may not deliver the expected therapy. Other AEDs not affected by this action should remain in service.
All affected AEDs will be replaced at no charge to the customer. Cardiac Science is contacting affected customers and sending replacement AEDs.
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@example.com for more information.