Recall Z-0984-05 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 20 defbrillator/monitor
| Date | Jul 13, 2005 (initiated Jun 17, 2005) |
| Status | Terminated |
| Reason | The defibrillator may not operate if the device is turned on during an AC Loss Alert. |
| Root cause | Other |
| Action | On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software. |
| Quantity | 3924 units |
| Distribution | Devices were distributed to hospitals and medical centers 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 |