Cardiac Science Powerheart, CardioVive, CardioLife;
GE Responder and Responder Pro; and Nihon-
Kohden Automated External Defibrillators (AEDs)
Recall Class: Class I
Date Recall Initiated: January 13, 2012
- Cardiac Science Powerheart, CardioVive, and CardioLife Models of AEDs
- GE Responder and Responder Pro AEDs
- Nihon-Kohden AEDs
Affected Models: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532, 92533;
CardioLife 9200G and 9231; GE Responder and Responder Pro; and Nihon-Kohden AEDs
Go to Serial Number Search1 to determine if an AED is affected by this recall. Enter one or more serial
numbers, located on the back of the AED, in the box provided on the firm's webpage.
These AEDs were manufactured and distributed from July 1, 2011 through December 30, 2011.
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, Washington 98021
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53118-1615
Nihon Kohden Corporation
1-31-4, Nishiochiai Shinjuku-ku
Tokyo, 161-8560, Japan
Reason for Recall: The affected AEDs contain a component that may fail unexpectedly due to a defect. If
the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy causing
serious adverse health consequences, including death. The unit's self test may not detect the failure or
impending failure of the component.
Public Contact: Customers may contact the firm at 1-888-402-2484 (in the U.S.) and +1-425-402-2482
(outside the United States) or by email at email@example.com.
FDA District: Seattle
FDA Comments: On January 13, 2012, the firm sent all affected customers an URGENT-Voluntary
Medical Device Recall letter. The letter describes the product, problem, and actions to be taken by the
Affected customers are advised to contact the firm to arrange for delivery of shipping materials for an
immediate return of their AEDs for repair. The affected devices will receive a hardware correction, and
the same serial number device will be returned to the customer in most cases. All affected AEDs will be
corrected at no charge to the customer.
Customers and distributors can also visit www.cardiacscience.com/aed210 for more information about the
AEDs affected by this recall (including Frequently Asked Questions).
Class I 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 adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they
experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event
Reporting Program either online, by regular mail, by telephone, or by FAX.