www.safetyandhealthmagazine.com/articles/fda-issues-aed-recall-2

FDA issues AED recall

March 7, 2012

Washington – The Food and Drug Administration has announced a recall of certain automated external defibrillators due to a defective component.

The defect could cause the AED to fail during a rescue attempt, and the unit’s self-test may not detect the impending failure of the component, FDA said.

The AEDs were made and sold between July 1, 2011, and Dec. 20, 2011. Affected models include:

  • Powerheart 9300A, 9300E, 9300P, 9390A and 9390E
  • CardioVive 92532 and 92533
  • CardioLife 9200G and 9231
  • GE Responder and Responder Pro
  • Nihon-Kohden AEDs

FDA said customers should contact the manufacturer to return the device for repair.