Recall Z-0495-05 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 12 defibrillator/ monitors biphasic
| Date | Feb 3, 2005 (initiated Jan 15, 2005) |
| Status | Terminated |
| Reason | The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so. |
| Root cause | Software design |
| Action | The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings. |
| Quantity | 28,835 devices distributed in the U.S.; 15,613 devices distributed internationally |
| Distribution | 28,835 devices were shipped to 6874 domestic consignees. |
| FDA record | Open on fda.gov |