Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E
FDA Recall Z-0806-05 · Posted 2005-05-12
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Recalling FirmMRL, Inc., A Welch Allyn Company
Recall StatusTerminated
Product CodeMKJ
Date Initiated2005-04-28
Date Terminated2006-09-01
Product Quantity597
Reason for Recall
The Welch Allyn AED 20 product 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 appropiate therapy.
Firm Action
Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.
Root Cause
Device Design
Distribution Pattern
Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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