QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
FDA device recall Z-0116-06 · posted 2005-11-02 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Potential for voltage pins in connector of therapy cable to break.
- Action taken
- On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- total for both types - 52,654
- Distribution
- Devices were distributed worldwide.
- Date initiated
- 2005-09-02
- Date posted
- 2005-11-02
- Date terminated
- 2011-01-17
- 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 |