FDAnews Device Daily Bulletin

FDA POSTS CLASS I RECALL FOR WELCH ALLYN AUTOMATED EXTERNAL DEFIBRILLATORS

June 21, 2006
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The FDA has posted a Class I recall of Welch Allyn's AED 20 automated external defibrillators manufactured from April through October 2003, serial numbers 205199 through 205786.

These devices are intended for use by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest. The devices analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

An electrical connection within the recalled devices may fail intermittently, impairing the device's ability to analyze the patient's heart rhythm and deliver appropriate therapy. This could result in delay or failure to resuscitate the patient. This may be associated with an error message on the device display reading "DEFIB COMM FAIL SELF TEST FAILED."

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

To view the recall, access http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html (http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html).