Recall Z-0918-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
MRL, Inc., A Welch Allyn Company
Welch Allyn AED 10 Defibrillator; a battery powered automated external defibrillator; Manufacturer: MRL, Inc., A Welch Allyn Company, 100 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED10, part numbers 970300 (defibrillator) and 970302 (defibrillator with soft shell carrying case)
| Date | Jul 20, 2004 (initiated Apr 26, 2004) |
| Status | Terminated |
| Reason | A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator. |
| Root cause | Other |
| Action | Urgent Medical Device Recall letters dated 4/26/04 were sent to the end users via certified mail on 4/26/04. The letters informed the users of the intemittent shock (fire or 3) button failure on the AED 10. The letters included a list of the affected serial numbers, and requested the users to call Welch Allyn MRL Technical Support as soon as possible at 1-800-462-0777 for a replacement AED 10 and to answer any questions. A replacement AED 10 will be sent to the end users within 10 days, and the users were requested to return their AED 10 in the same shipping box accompanying the replacement |
| Quantity | 460 units |
| Distribution | Nationwide, and internationally to the United Kingdom, Ireland, Singapore, France and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021168 | JUMP START, MODEL 970300 Medical Research Laboratories, Inc., Jun 26, 2002 |