Alsius CoolGard Temperature Regulation System
FDA device recall Z-0369-06 · posted 2006-01-10 · Terminated
Recall details
- Recalling firm
- Alsius Corporation
- Reason for recall
- Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
- Action taken
- Alsius Corporation is notifying customers of an issue requiring service of their CoolGard 3000 by letter shipped via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 239
- Distribution
- Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom
- Date initiated
- 2005-11-09
- Date posted
- 2006-01-10
- Date terminated
- 2007-02-05
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (K030421) | Alsius Corp. | 2003-10-23 |
| COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) | Alsius Corp. | 2003-08-01 |