Cardiac Science Recalling About 12,200 AEDs
The Feb. 3 announcement is separate from a Nov. 13, 2009, voluntary device correction the company had issued.
The FDA posted a recall notice today announcing Cardiac Science had begun a worldwide voluntary recall of about 12,200 automated external defibrillators on Feb. 3. The company's announcement is separate from its Nov. 13, 2009, voluntary device correction, and it affects Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532; and CardioLife 9200G and 9231 units that were manufactured or serviced between Oct. 19, 2009, and Jan. 15, 2010, according to the company.
Cardiac Science said the affected AEDs "may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation."
Customers who received an AED since Oct. 19, 2009, may check a table posted by Cardiac Science to determine whether they have an affected AED. If they do, it should be immediately removed from service. "All affected AEDs will be replaced at no charge to the customer. Cardiac Science will contact customers and will send replacement AEDs as soon as they are available. Replacement shipments are anticipated to begin Feb. 15," according to the company.
For information, contact the company at 888-402-2484 within the United States or at +44.161.926.0011 if outside the United States. Customers may e-mail firstname.lastname@example.org for more information.