FDA, Cardiac Science Announce AED Recall

Cardiac Science and the FDA are notifying healthcare professionals and consumers of a Class 1 recall of Cardiac Science's automated external defibrillators (AEDs). The affected units might not deliver therapy during a resuscitation attempt, and the malfunctioning might not be detected during the unit's self-tests.

Other problems with the units might include interruption of ECG analysis that prevent shock delivery, failure to recognize pad placement during use and interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if the ECG analysis was successfully conducted.

These problems could potentially lead to adverse health effects or even death.

Affected models include:

• Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
• CardioVive 92531, 92532, 92533
• NK 9200G, 9231
• Responder 2019198, 2023440

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