280K Defibrillators At Risk For Malfunction, FDA Warns

Law360, New York (April 27, 2010, 5:03 PM EDT) -- The U.S. Food and Drug Administration has warned that close to 280,000 external defibrillators made by Cardiac Science Corp. could malfunction when used on patients experiencing sudden cardiac arrest.

The FDA expanded the recall, which was first announced in November, on Tuesday to include several new defibrillator models made by GE Responder and Nihon Kohden.

“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,” Jeffrey Shuren, M.D., J.D., director of...
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