Recall Z-1005-2009 ยท MKJ Automated External Defibrillators (Non-Wearable)
Welch Allyn Protocol, Inc
Welch Allyn AED 10 Automated External Defibrillator
| Date | Mar 10, 2009 (initiated Dec 15, 2008) |
| Status | Terminated |
| Reason | Potential for device to shut down prematurely under certain circumstances. |
| Root cause | Device Design |
| Action | On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00. |
| Quantity | 89 units |
| Distribution | Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom. |
| 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 |