Healthcare Industry News: automated external defibrillator
News Release - July 19, 2010
Cardiac Science Updates AED Customers Affected by November 2009 RecallBOTHELL, Wash., July 19 (Healthcare Sales & Marketing Network) -- 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.
U.S. customers may call 877.901.1788 for more information regarding this update.
This press release contains forward-looking statements. The words "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, those that refer to the number of AEDs expected to be repaired or replaced under the updated recall plan, the timing of replacement, the resolution of regulatory concerns in both the U.S. and foreign jurisdictions, the effectiveness of the software update and the risk of component failure. 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 include the outcome of discussions or negotiations with applicable regulatory bodies in geographies outside the U.S., additional regulatory issues that may arise in the course of our business due to the fact that we remain subject to the oversight of the FDA and other regulatory bodies, as well as those 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, and may include lack of financial resources to perform the replacements and other actions described herein. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
Source: Cardiac Science
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