Recall Z-0806-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
MRL, Inc., A Welch Allyn Company
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
| Date | May 12, 2005 (initiated Apr 28, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 597 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002232 | AEDEFIBRILLATOR Medical Research Laboratories, Inc., Dec 6, 2000 |