Cardiac Science Corporation has just implemented a worldwide recall after it determined that about 12,200 <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt. This defect could lead to serious adverse events or death.
The recalled AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The U.S. Food and Drug Administration (FDA) has been informed of this situation, said Cardiac Science Corporation.
Meanwhile, in a separate incident, Cardiac Science Corporation announced a voluntary medical device correction on November 13. This issue is separate from the Company’s November 13 announcement regarding a voluntary medical device correction.
Cardiac Science said it detected this issue through its internal quality systems and has received no complaints or reports of this problem in the field. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models:
â€¢ Powerheart 9300A, 9300E, 9300P, 9390A, 9390E
â€¢ CardioVive 92532
â€¢ CardioLife 9200G and 9231
Customers who received any of these AED models since October 19, 2009 can visit http://www.cardiacscience.com/AED195 to determine if they have a recalled AED. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.
Cardiac Science noted that all affected AEDs will be replaced at no charge to the customer. Cardiac Science will also contact customers by letter and will provide them with replacement AEDs as soon as they are available. Replacement shipments are anticipated to begin February 15.
Customers can reach Cardiac Science by telephone toll-free in the United States at 1.888.402.2484 or direct, internationally at +44.161.926.0011; by contacting a local Cardiac Science representative; or by email at firstname.lastname@example.org.
In October we wrote that Philips Healthcare recalled approximately 5,400 of its HeartStart FR2+ automated external defibrillators because a potential memory chip failure could render the device inoperable.
Just prior, in September, we wrote that Physio-Control, Inc., a division of Medtronic, Inc., recalled LifePak CR Plus AEDs in what the U.S. Food & Drug Administration (FDA) deemed a Class I recall. According to the recall notice, an extremely humid environment may cause the LifePak CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.