LIFEPAK 20 automatic external defibrillator
FDA device recall Z-0295-2007 · posted 2006-12-19 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 10,307 devices as of 9-19-06
- Distribution
- Devices were distributed to hospitals and clinics worldwide.
- Date initiated
- 2006-03-16
- Date posted
- 2006-12-19
- Date terminated
- 2011-03-29
- Location
- Redmond, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |