Class I Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden 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
Fri Jan 13 2012
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.
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