Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
FDA device recall Z-0859-06 · posted 2006-05-10 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.
- Action taken
- Consignees were notified by telephone followed by a fax on 04/21/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 137 units
- Distribution
- Nationwide. AZ, CA, CO, CT, FL, GA, IL, MA, MI, MN, MO, MS, NC, NE, NJ, OH, OK, PA, TX, VA. Foreign distribution to Argentina, Canada, Chile, Costa Rica, France, Greece, Israel, Peru, Singapore.
- Date initiated
- 2006-04-21
- Date posted
- 2006-05-10
- Date terminated
- 2009-02-26
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COOL-TIP RF SYSTEM (K984552) | Radionics, Inc. | 1999-03-05 |