Recall Z-1007-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Welch Allyn Protocol, Inc
Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")
| Date | Mar 10, 2009 (initiated Dec 15, 2008) |
| Status | Terminated |
| Reason | Potential for device to deliver less than the programmed energy. |
| Root cause | Process control |
| Action | Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009. |
| Quantity | 14,012 devices |
| Distribution | Worldwide distribution. |
| 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 |