| Product Description | Model/Product Number | Stock Identifiers | Volume | Recall ID |
| Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator. | Model AED20, Part 972200, Catalog # 972211, 972212, 972213, 972214, 972215 and 972216 | (a) Serial numbers 205199 through 205786 , except for 205213 , 205236 , 205237 , 205238 , 205239 , 205240 , 205242 , 205243 , 205247 , 205307 , 205308 , 205309 , 205465 , 205653 , 205654 , 205656 , 205664 , 205665 , 205667 , 205669 , 205677 , 205678 , 205684 , 205703 , 205708 , 205719 , 205732 , 205736 , 205754 , 205756 , 205760 , 205762 , 205763 , 205764 , 205767 , 205774 , 205775 , 205777 , 205781 , 205782 , 205784. Also included in the recall are serial numbers 201784 , 202804 , 205179 , 205790 , 205806 , 205808 , 205818 , 205842 , 205866 , 206076 , 206078 , 206079 , 206080 , 206081 , 206096 , 206125 , 206131 , 206137 , 206138 , 206140 , 206162 , 206164 , 206175 , 206177 , 206180 , 206216 , 207511 , 207518 , 207520 , 207521 , 207522 | 580 units total. | Z-1106 |
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AED Recalls
| Alert Details for #2006060370 (Released 6/27/2006 18:53 EDT) | |
| Description: | Update to RASMAS alert # 2006060209 of 6/9/06 (Serial Numbers NOT included in sequence enumerated and Catalog #s specified) Welch Allyn AED 20 Automated External Defibrillator |
|---|---|
| Manufacturer: | MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL |
| Reason: | The Welch Allyn AED 20 Defibrillators 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. |
| Analyst Comments: | Confirm receipt of manufacturer's notice dated June 15, 2006. If this product is in your inventory, please contact the manufacturer, distributor, or your service representative for additional information. Customers with questions may contact the company at 1.800.462.0777 or 1.847.520.0300 or www.welchallyn.com. |
| Alert Type: | Recall URGENT | Source Alert Type: | FDA CLASS I |
|---|---|---|---|
| Domain: | Biomedical Devices | Source Type: | FDA Enforcement Report |
| Distribution: | United States and Internationally | Source Date: | 6/28/2006 |
| Links: |
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| http://www.fda.gov/po/enforceindex/2006enforce.html |
| Product Information |