Date Recall
Initiated:

June 15, 2006

Product:

Welch Allyn AED 20™ Automated External Defibrillators manufactured from April through October 2003, serial numbers 205199 through 205786.

Use:

These devices are intended for use by emergency or medical personnel to treat adult and pediatric patients in cardiopulmonary arrest (heart attack). 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.

Recalling Firm:

MRL, Inc., A Welch Allyn company
1000 Asbury Drive
Suite 17
Buffalo Grove, IL 60089-4551

Reason for Recall:

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.”

Public Contact:

Questions can be directed to the company at (800)462-0777 or (847)520-0300 for more information.

FDA District:

Chicago

FDA Comments:

• MRL, Inc sent letters via certified mail on June 14, 2006 to its customers who purchased AED20’s in this group of devices.
• Owners of this defibrillator should contact MRL, Inc. to obtain a loaner AED20 at no cost while their unit is being serviced.
• MRL, Inc. will pay all costs associated with shipping, handling and replacement of the units’ “DEFIB” board.

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.

For additional information on this product recall, see the company’s press release at http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html.