March 5, 2012
Cardiac Science Corporation Recalls Automated External Defibrillators
The Missouri Department of Health and Senior Services received the following news release regarding
Automated External Defibrillators (AEDs). 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. AEDs are used for emergency treatment of victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing.
- 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.
The AEDs were manufactured and distributed from July 1, 2011 through December 30, 2011.
The full recall can be found at www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm294452.htm.