MedWatch - The FDA Safety Information and Adverse Event Reporting Program
MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators. An intermittent electrical connection within the device may result in failure or unacceptable delay in analyzing the patient’s CG, failure to deliver appropriate therapy and failure to resuscitate the patient. FDA defines a Class I recall as one in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
Read the complete MedWatch 2006 Safety summary, including links to the FDA recall notice and the firm press release, at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#AED20