Recall Z-1006-2009 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 9, 2009 (initiated Dec 15, 2008) |
| Status | Terminated |
| Reason | Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm; |
| Root cause | Component design/selection |
| Action | Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00. |
| Quantity | 10, 735 |
| 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 |