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FDA Warns Users About Faulty Components in 14 External Defibrillator Models
Date:4/27/2010

ardioVive models 92531, 92532 and 92533
  • Nihon Kohden models 9200G and 9231 and
  • GE Responder models 2019198 and 2023440.

  • The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.

    For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

    If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy.  The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

    "The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

    Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.

    Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue si
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    SOURCE U.S. Food and Drug Administration
    Copyright©2010 PR Newswire.
    All rights reserved

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