Automated external defibrillators are computerized medical devices that can check a person’s heart rhythm, recognize a rhythm that requires a shock, and advise rescuers on the appropriate steps to take. These types of defibrillators are available in EMS first-response vehicles, as well as many private and public places where large numbers of people gather. The U.S. Food and Drug Administration (FDA) announced earlier this week that defibrillators made by Cardiac Science are being recalled due to a manufacturing problem that may prevent them from delivering life-saving therapy.

Cardiac Science is recalling and replacing over 12,000 automated external defibrillators. The company has advised that customers take the following defibrillators out of service: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532; and CardioLife 9200G and 9231. Customers who have received any of these defibrillators since October 19, 2009 should contact Cardiac Science for a replacement. Replacements are expected to be shipped out beginning on February 15, 2010.

To date, Cardiac Science has not received any reports of adverse events or complaints about these defibrillators. The company stated that the problem with the defibrillators was detected by its own internal quality control systems.

Source:

U.S. Food and Drug Administration press release, 9 February 2010.