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 box 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.
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.
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 email@example.com for more information.
For more information, see Useful Links below.
FDA District: Seattle
On November 13, 2009, the company mailed a recall letter to their customers instructing them to perform preventive measures.
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.
- FDA Initial Communication - Defective Cardiac Science Corporation AEDs
- Firm Press Release
- MedWatch Adverse Event Reporting Program