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U.S. Department of Health and Human Services

Safety

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MRL Inc. AED20 Automatic External Defibrillators

Audience: Emergency healthcare professionals and Cardiologists
MRL Inc. and FDA notified healthcare professionals of a voluntary worldwide recall of 597 AED20 Automatic External Defibrillators manufactured between February and July of 2004. The AED20 may display a “Defib Comm” error message during use resulting in a failure of the device to analyze the patient’s ECG and deliver the appropriate therapy which prevents the defibrillator from resuscitating a patient. The company has received 12 related complaints with this specific group of AED20’s, including one instance which may have prevented patient resuscitation.
 

[May 13, 2005 - Recall Notice - FDA]
[May 10, 2005 - Press Release - MRL Inc.]