Posted on 09/18/2007

September 18, 2007–MRL/WelchAllyn has issued a Class I recall of Automated External Defibrillators (AEDs) manufactured between October 2003 and January 2005 (serial numbers 205787 through 207509).

According to the Food and Drug Administration (FDA) in a message updated September 18th, the recalled devices may display a “Defib Comm” error message on the device display during use, which “may result in a terminal failure of the device to analyze the patient’s ECG and deliver the appropriate therapy.”

Class I recalls are the most serious FDA recalls. The FDA issues Class I recalls when there is a good chance that the use of a medical device could cause serious injury or death. According to the FDA, emergency and medical personnel should stop using the AED 20 Automatic External Defibrillators immediately.

WelchAllyn sent recall letters on August 29, 2007, to customers who purchased the devices. Device owners should contact their local WelchAllyn representative to obtain a loaner AED 20™ at no cost while their unit is being serviced. WelchAllyn will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices.

For more information, call WelchAllyn at 800-462-0777 or visit www.fda.gov.