Recall Z-0542-03 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Physio Control Corp
LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. P
| Date | Feb 5, 2003 (initiated Jan 27, 2003) |
| Status | Terminated |
| Reason | Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit. |
| Root cause | Other |
| Action | Consignees were notified of recall action by letter dated January 2003. Letter advised consignees to follow recommendations for periodic inspections and to test device to verify readiness. A few weeks later the consignees were sent a correction letter along with user installable shields. |
| Quantity | domestic: 30,575 foreign: 15,467 |
| Distribution | Worldwide distribution, including government/military accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002445 | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES Medtronic Physio-Control Corp., Jan 31, 2001 |
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Medtronic Physio-Control Corp., Aug 23, 2001 |
| K973486 | LIFE PAK 12 Physio-Control Corp., Jan 9, 1998 |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Physio-Control Corp., Sep 1, 1999 |
| K991910 | LIFEPAK 12 BIPHASIC Physio-Control Corp., Sep 3, 1999 |