FDAnews Device Daily Bulletin

MRL ISSUES CLASS I RECALL OF AUTOMATED EXTERNAL DEFIBRILLATORS

June 20, 2006
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Devicemaker MRL has issued a Class I recall of Welch Allyn AED 20 automated external defibrillators.

After receiving 30 complaints related to the devices, the Buffalo Grove, Ill.-based firm is recalling 580 devices manufactured from April through October 2003. The devices treat heart attacks by analyzing a patient's heart rhythm and delivering an electrical shock to the heart to restore normal rhythm.

An intermittent electrical connection can cause an error message to appear on the device display, leading to a delay in resuscitation or a failure to resuscitate the patient, the firm said.

The recall notice can be viewed at http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html (http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html).