LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
FDA device recall Z-0294-04 · posted 2004-01-06 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Device unable to recognize the connection to the hard paddles accessory.
- Action taken
- Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKI
- Quantity affected
- 180 sets
- Distribution
- The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
- Date initiated
- 2003-11-12
- Date posted
- 2004-01-06
- Date terminated
- 2004-02-25
- 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 |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |