Safety Notice for Powerheart, Cardio Vive and Responder Defibrillators, Cardiac Science
2010.09.14
Product group Medical electronics / Electromedical devices
Reference 04355/09
The Cardiac Science Corp. has issued a Field Safety Notice concerning a corrective action of the automated external defibrillators Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E and Cardio Vive models 92531, 92532 and 92533 as well as Responder models 2019198 and 2023440, manufactured between August 2003 and August 2009. Due to inability of the periodic self-tests to detect failures of certain electronic components there is the risk that these AEDs are not be able to deliver therapy during a rescue attempt.