BOTHELL, Wash., July 19 /PRNewswire-FirstCall/ -- 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.
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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.
Forward-Looking Statements
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.
For more information,
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Company Contact:
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Investor Contact:
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Media Contact:
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Mike Matysik
Cardiac Science
Corporation
Senior Vice President and
CFO
425.402.2009
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Matt Clawson
Allen & Caron
949.474.4300
matt@allencaron.com
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Christopher Gale
EVC Group Inc.
646.201.5431
203.570.4681
cgale@evcgroup.com
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CSCX-F
SOURCE Cardiac Science Corporation