Cardiac Science Corporation Issues Class I Recall for External Defibrillators

A number of eternal defibrillators have been recalled, the U.S. Food and Drug Administration (FDA) just announced in what it has deemed a Class I recall.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

The recalled automated external defibrillator (AED) models, which were manufactured and distributed from July 1, 2011 through December 30, 2011, include:

• Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E
• CardioVive 92532, 92533
• CardioLife 9200G and 9231
• GE Responder and Responder Pro
• Nihon-Kohden AEDs

The recall is being issued by Cardiac Science Corporation. The affected devices were distributed by either GE Healthcare, LLC or Nihon Kohden Corporation.

These defective defibrillators are used for the emergency treatment of victims who show symptoms of sudden cardiac arrest and who are unresponsive and not breathing.

The FDA advised healthcare professionals and medical care organizations of the Class 1 recall of these AEDs. The AEDs contain a component that may fail unexpectedly, due to a defect. If the component fails during a rescue attempt, the AED may not deliver defibrillation therapy, which could cause serious adverse health consequences, including death. Also, the unit’s self test may not detect the component’s failure, or the component’s impending failure.

Affected customers are advised to contact the firm to arrange for delivery of shipping materials for an immediate return of their AEDs for repair. Affected AEDs will receive a hardware correction, and the same serial number device will be returned to the customers, in most cases.

A serial number search tool is available at:, supplied by Cardiac Science, the recalling firm. Enter one or more serial numbers, located on the back of the AED, in the box provided on the firm’s webpage.

Cardiac Science Corporation is located at 3303 Monte Villa Parkway,
Bothell, Washington, 98021; distributors are GE Healthcare, LLC
3000 N Grandview Boulevard, Waukesha, Wisconsin 53118-1615 and Nihon Kohden Corporation
1-31-4, Nishiochiai Shinjuku-ku
Tokyo, 161-8560, Japan. Cardiac Science can be reached, toll-free, at 1.888.402.2484, or 1.425.402.2482 (outside the United States), or by email at

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.