Recalling Firm / Manufacturer

Welch Allyn Protocol, Inc.

Product

MRL/Welch Allyn AED 20™ Automatic External Defibrillators manufactured between October 2003 and January 2005.

Code Information

serial numbers 205787 through 207509.

Reason of Recall

These 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.

Date Recall Initiated

August 24, 2007

Action

Welch Allyn sent recall letters on August 29, 2007 to its customers who purchased these devices.

Owners of this defibrillator should contact their local Welch Allyn representative to obtain a loaner AED 20™ at no cost while their unit is being serviced.

Welch Allyn will pay all costs associated with the upgrade required to correct the issue as well as shipping and handling of the devices.

Contact

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.