Cardiac Science issues update on AED recall announced in November 2009

Jul 20 2010

Cardiac Science Corporation (Nasdaq: CSCX) has issued an update to customers affected by a recall first announced by the Company on November 13, 2009. Under an updated recall plan developed by the Company and reviewed by the FDA, certain U.S. customers are eligible for device replacement. The FDA has issued an updated communication on this matter which may be viewed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191426.htm.

Under this plan, Cardiac Science will replace approximately 24,000 AEDs used by certain first responders and medical facilities in the United States. First responders include police, fire and ambulance services. Medical provider facilities include hospitals, certain medical clinics, dialysis centers, and assisted living facilities. AED use by these customers is likely to be more frequent due to the nature of the settings in which the AEDs are employed and the involvement of professionally trained caregivers. More frequent use of affected AEDs may introduce a slightly higher probability that the component issue that led to the November 2009 recall will be encountered during a rescue attempt.

Cardiac Science will notify first responder and medical facility customers with affected AEDs. Replacements for these customers will be scheduled as soon as possible, with first priority given to police, fire and ambulance service customers.

All other AEDs covered by the November 2009 recall require only the Company's previously announced software update, which enhances the AED's self-test capabilities and improves detection of the component issue. The Company has notified affected customers and the software update is currently available for all affected AEDs. For most models, the update is available online at www.cardiacscience.com/aed175. Cardiac Science urges all users, including those who will receive replacements, to install the software update for their affected AED as soon as possible. After installing the update, if customers determine their AED is not rescue ready (the status indicator is red), they should contact Cardiac Science Technical Support at 800.426.0337 (option 1) to arrange for repair or replacement.