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U.S. Department of Health and Human Services

Medical Devices

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Cardiac Science Corporation - Powerheart, Cardiovive, NK, and Responder Automated External Defibrillators (AEDs)

Recall Class: Class I

Date Recall Initiated: November 13, 2009

Product: Cardiac Science Corporation Automated External Defibrillators

The following models are affected by this recall:

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

To conduct a serial number search, enter one or more serial numbers into the search boxExit Disclaimer on the company’s website. The serial number is located on the back of the device.

The affected AEDs were manufactured and distributed between August 2003 and August 2009.

Use: This product is used for emergency treatment of victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing.

Recalling Firm:

Cardiac Science Corporation
3303 Monte Villa Parkway
Bothell, WA 98021-8969

Reason for Recall:

These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death.

Public Contact:

Customers may contact the company at 1-800-426-0337, option 1, within the U.S. Outside the U.S., customers can contact the company at +44-161-926-0011 or the local Cardiac Science representative. Customers can also email the company at aed175@cardiacscience.com for more information.
For more information, see Useful Links below.

FDA District: Seattle

FDA Comments:

On November 13, 2009, the company mailed a recall letter to their customers instructing them to perform preventive measures.Exit Disclaimer

The firm plans to provide a software upgrade that will enhance the devices’ failure detection capabilities.

On November 19, 2009, FDA issued an initial communication for these AEDs. See below under Useful Links.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.

Useful Links: