Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
November 14th, 2009 · No Comments
Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests.
Tags: FDA · FDA Recalls
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