Recall Z-0295-2007 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 automatic external defibrillator
| Date | Dec 19, 2006 (initiated Mar 16, 2006) |
| Status | Terminated |
| Reason | LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. |
| Root cause | Other |
| Action | Letter dated December 2006 alerts users to the lock-up problem, and suggesting a procedure to prevent lock-up. Firm promised another letter in January 2007 detailing the plan to provide software upgrade. |
| Quantity | 10,307 devices as of 9-19-06 |
| Distribution | Devices were distributed to hospitals and clinics worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER Medtronic Physio-Control Corp., Feb 5, 2002 |