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U.S. Department of Health and Human Services

Safety

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Access CardioSystems Automated External Defibrillators

Audience: Public health organizations, emergency medical services personnel, and consumers

FDA and Access CardioSystems, Inc. notified the public of the Class 1 recall of Access CardioSystems Automated External Defibrillators (AEDs), used for the treatment of cardiac arrest by hospitals, fire departments and emergency medical services personnel. Approximately 10,000 devices are in distribution. One or both of the following problems may occur - 1] the defibrillator may fail to deliver a shock due to a faulty circuit board, and 2] the defibrillator may turn on unexpectedly causing the “on/off” switch to become inoperative, making the device unable to defibrillate. Customers should immediately stop using the recalled devices.

[November 19, 2004 - Recall Notice - FDA]
[November 10, 2004 - Press Release - FDA]