BOTHELL, Wash., April 28 Cardiac Science Corporation (Nasdaq: CSCX), responded to FDA communications released yesterday related to the AED recall first announced in November, 2009. The Agency communication specifies additional affected models and offers further guidance to users of AEDs affected by potential component defects in some of the Company's AEDs.
THIS IS NOT A NEW RECALL. The FDA communications pertain to a voluntary recall initiated by the Company in November, 2009. This recall addresses potential component defects that can affect approximately 280,000 AEDs manufactured between August, 2003 and August, 2009. As previously announced by the Company, the corrective action consists of a software update designed to enable the AED's self-test to detect failed components. The software update is already available for some AED models and thousands of users have already downloaded and installed the update.
NEW UNITS ARE NOT AFFECTED. The Company improved its manufacturing processes in August, 2009. All units produced by the Company since, including units currently being sold and shipped, are not affected by this issue.
THE RECALL HAS NOT EXPANDED. The FDA clarified the list of affected AEDs to include those the Company manufactures for Nihon Kohden (NK) and General Electric (GE). These units were not identified in previous public communications because NK and GE agreed to tell their customers. However, the Company disclosed the NK and GE units to the FDA in previous communications about the total recall population.
The FDA communication also stated the Company's software upgrade identifies "some but not all electrical component defects." While the software does not detect every possible mode of component failure, it does effectively detect those failures that have been reported to have caused an AED to fail to deliver therapy during a rescue. With this update, the Company estimates the probability an AED would fail to deliver therapy due to undetected failure of the components in question drops to 1 in 1,800,000 per year.
"Our users are foremost in our considerations," said Dave Marver, Cardiac Science president and CEO. "We want to be certain our users have a complete understanding of this recall, including the accompanying risks and probabilities, so they can make informed decisions about these life-saving devices."
Customers will be notified by letter when the software update for their affected model is available. The software update download is available for certain models at http://www.cardiacscience.com/AED175. At that site, customers who prefer printed documentation and a CD with the software update from the Company may request it.
As before, the Company strongly advises customers to follow the normal testing and maintenance procedures found in the Operator and Service Manual. A copy of these procedures is available at http://www.cardiacscience.com/AED175. At this site, customers may confirm if their AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance.
If customers have any questions or concerns regarding this issue, they can contact Cardiac Science through their dedicated help lines at 877.901.1788 or 425.402.2484 and visit the Web site http://www.cardiacscience.com/AED175.
This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions concerning the likelihood of AED component failure, and the timing, delivery and effectiveness of the software update described above. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2009, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
For updates and information on worldwide defibrillation and cardiac monitoring, find us on the Cardiac Science blog at http://www.cardiacscience.com/blog, Twitter at http://twitter.com/cardiacscience, Facebook at http://budurl.com/CSonFB, YouTube at http://www.youtube.com/user/CardiacScience.
For more information,
Cardiac Science Contact: Investor Contact: Media Contact: ------------------------ ----------------- -------------- Mike Matysik Matt Clawson Christopher Gale Cardiac Science Corporation Allen & Caron EVC Group Inc. Senior Vice President and CFO 949.474.4300 646.201.5431 425.402.2009 [email protected]
203.570.4681 [email protected]
SOURCE Cardiac Science Corporation