Recall Z-0369-06 ยท NCX System, Hypothermia, Intravenous, Cooling
Alsius Corporation
Alsius CoolGard Temperature Regulation System
| Date | Jan 10, 2006 (initiated Nov 9, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |