FDA: Automated External Defibrillators Recalled

Cardiac Science recalls defibrillators due to inability to deliver therapy during resuscitation
By Beth Gilbert
HealthDay Reporter

THURSDAY, Feb. 11 (HealthDay News) -- Cardiac Science Corporation has announced the worldwide voluntary recall of a number of their automated external defibrillators (AEDs) due to the inability of these devices to deliver therapy during resuscitation, which can result in serious complications and death, according to a Feb. 9 safety alert issued by the U.S. Food and Drug Administration.

In this voluntary recall of approximately 12,200 AEDs, the company states that the affected devices are potentially susceptible to failure under certain conditions. Cardiac Science Corporation determined the problem through quality control and has identified the exact AED models affected in the recall, which include Powerheart 9300A, 9300E, 9300P, 9390A and 9390E, CardioVive 92532, and CardioLife 9200G and 9231. These devices were manufactured or serviced between Oct. 19, 2009 and Jan. 15, 2010.

Concerned customers may access the company's Web site to determine if they have an affected device. Any affected devices should immediately be removed from clinical practice due to their potential inability to deliver therapy.

"All affected AEDs will be replaced at no charge to the customer. Cardiac Science will 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," states the Feb. 3 press release issued by the manufacturer.

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