| Recall Date: 01/13/2012 |
| Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall |
| Units: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs) selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide. |
| Issue: Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies. |
| Fix: enter serial number, if on the list contact Cardiac Science and have repaired at no cost. |
| Alert Documentation |