Cardiac Science (NASDAQ: CSCX) will replace 24,000 automated external defibrillators as part of a revision to a recall plan that it has worked out with the FDA. The company announced last November that a certain AEDs may, in rare instances, not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death.
Cardiac Science initially issued a recall for its Powerheart and CardioVive models. However, the FDA says it's learned that Cardiac Science defibrillators marketed by Nihon Kohden and GE Healthcare have similar problems, Mass Device reports. The recall has already cost Cardiac Science $18.5 million, and the company expects this latest action will add $10 million to $15 million to the total cost.
Under the updated recall plan, the company will replace AEDs used by certain first responders and medical provider facilities in the U.S., where devices are more often used. The more frequent use of affected AEDs may introduce a slightly higher probability the component issue leading to the November 2009 recall will be encountered during a rescue attempt, the company says in a statement. All other AEDs affected by the November 2009 recall require only the previously announced software update. This update is designed to enhance the AED's self-test capability and improve detection of the component issue. It is now available for all affected models.
- see the Cardiac Science release
- read the Mass Device article