Date Recall Initiated |
August 24, 2007 |
---|---|
Product: |
MRL/Welch Allyn AED 20™ Automatic External Defibrillators manufactured between October 2003 and January 2005, serial numbers 205787 through 207509. |
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: |
Welch Allyn Protocol, Inc. 8500 Sw Creekside Pl Beaverton, OR 97008 |
Reason for 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. |
Public Contact: |
Customers may call the company at 1-800-462-0777. |
FDA District: |
Seattle |
FDA Comments: |
|
Updated September 25, 2007
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