Cardiac Science Recalls 12,200 AED Devices
Cardiac Science is initiating a worldwide voluntary recall of approximately 12,200 automated external defibrillators (AEDs) that may not be able to deliver therapy during a resuscitation attempt. The FDA has been notified.
An AED is a portable electronic device that automatically diagnoses cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat the condition through defibrillation – the application of electrical therapy which stops the arrhythmia, allowing the heart to reestablish an effective rhythm.
The models affected by the recall include the Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532; and the CardioLife 9200G and 9231. The devices were manufactured or serviced between October 19, 2009 and January 15, 2010. The AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions.
Cardiac Science detected the issue through its internal quality systems and has received no complaints or reports of problems in the field.
Customers unsure if their device is involved in the recall can visit the Cardiac Science website and use the “Serial Number Search” feature. Each affected AED should immediately be removed from service and returned to Cardiac Science for a replacement AED.
Customers may also contact the company at 888-402-2484 within the United States or email [email protected] for more information.
Cardiac Science is headquartered in Bothell, Washington, just north of Seattle. It also has operations in California, Wisconsin, China, Central Europe, Denmark, France and the United Kingdom. They offer cardiology products and services that include electrocardiographs, cardiac stress testing systems, and Holter monitors in addition to AEDs.