Cardiac Science Recall on Powerheart and CardiacVive AEDs

Cardiac Science issued a voluntary recall in November 2009 on Powerheart and Cardiac Vive AEDs. The FDA issued a warning letter about the defective AEDs.

During November 2009, Cardiac Science Corporation issued a voluntary recall on Powerheart and CardioVive automated external defibrillators (AEDs) manufactured during August 2003. The reason for the recall is due to the fact that the AED is failing to deliver an electrical shock. The self-test that the AED performs on itself does not show that there is an error with the machine. If a responder attempts to use the defective AED, then the victim has to potential to not receive an electrical needed to restart his or her heart.

Cardiac Science Corporation is correcting the issues with each of the affected AEDs by performing voluntary field corrections on the AED.The following Cardiac Science AED models are included in the voluntary recall:

• Powerheart models: 9300A, 9300C, 9300D, 9300E, 9390A, 9390E
• CardioVive models: 92531, 92532, 92533

If your organization owns one of either of these AED models, you are encouraged to contact Cardiac Science immediately to ensure your AED is not a defective model. The FDA has released a warning letter since Cardiac Science has issued its voluntary recall. The FDA felt that the voluntary recall that Cardiac Science was not sufficient, and felt that a warning letter needed to be released since the AED had the potential to fail to function properly. The FDA wanted to make sure the public knew of the severity of the defective AEDs. The FDA recommends that if another AED is available on site that it should be used in place of the Cardiac Science AED until Cardiac Science corrects the defective AEDs.

To view the FDA warning letter, please CLICK HERE.