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U.S. Department of Health and Human Services

Safety

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Welch Allyn AED20 Automatic External Defibrillators

Audience: Emergency Services personnel and risk managers

[Posted 06/16/2006] 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 ECG, 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.

[June 15, 2006 - Recall Notice - FDA]