LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both
FDA device recall Z-0542-03 · posted 2003-02-05 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- domestic: 30,575 foreign: 15,467
- Distribution
- Worldwide distribution, including government/military accounts.
- Date initiated
- 2003-01-27
- Date posted
- 2003-02-05
- Date terminated
- 2004-02-24
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |
| LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES (K002445) | Medtronic Physio-Control Corp. | 2001-01-31 |
| LIFEPAK 12 BIPHASIC (K991910) | Physio-Control Corp. | 1999-09-03 |
| NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K990338) | Physio-Control Corp. | 1999-09-01 |
| LIFE PAK 12 (K973486) | Physio-Control Corp. | 1998-01-09 |