Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators (AEDs)
Recall Class: Class I
Date Recall Initiated: October 12, 2009
Product(s): Cardiac Science Corporation Automated External Defibrillators
The following models are affected by this recall:
- Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
- CardioVive 92532, 92533
- Nihon Kohden 9200G, 9231
- GE Responder 2019198, 2023440
The affected devices were manufactured between November 2006 and February 2009.
For additional company information about this recall including serial number search visit: Manufacturer Service Announcement and Serial Number Search
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 98021-8969
Reason for Recall: Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory.
Public Contact: Customers may contact the company at 1-877-402-4599 within the U.S. or by email at AED155@cardiacscience.com for more information. Customers outside the U.S. should contact their local Cardiac Science representative.
FDA District: Seattle
The current recall is in addition to the firm’s November 2009 recall.
The firm initiated contact with customers beginning October 12, 2009, and sent a letter on October 13, 2009. The firm will be providing affected customers with replacement AEDs and asking them to return their affected AEDs.
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 adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
- Firm’s Service Announcement
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program