BOTHELL, Wash., — Cardiac Science Corporation 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.
About Cardiac Science
Cardiac Science, a wholly owned subsidiary of Opto Circuits (India) Ltd., develops, manufactures, and markets a family of advanced diagnostic and therapeutic cardiology devices and systems, including automated external defibrillators (AED), electrocardiograph devices (ECG/EKG), cardiac stress treadmill and systems, PC-based diagnostic workstations, Holter monitoring systems, hospital defibrillators, vital signs monitors, cardiac rehabilitation telemetry systems, and cardiology data management systems (informatics) that connect with hospital information (HIS), electronic medical record (EMR), and other information systems. The company sells a variety of related products and consumables and provides a portfolio of training, maintenance, and support services. Cardiac Science, the successor to the cardiac businesses that established the trusted Burdick®, HeartCentrix®, Powerheart®, and Quinton® brands, is headquartered in Bothell, Washington. With customers in almost 100 countries worldwide, the company has operations in North America, Europe, and Asia. For information, call 425.402.2000 or visit http://www.cardiacscience.com.
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 relating to Cardiac Science Corporation’s future AED sales in Japan, expected shipments of backordered products in the fourth quarter of 2010, and expectations regarding the closing of the transaction with Opto Circuits. 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 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. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.
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