Recall Z-1397-05 ยท NCX System, Hypothermia, Intravenous, Cooling
Alsius Corporation
Alsius CoolGard 3000 Temperature Regulation System
| Date | Aug 24, 2005 (initiated Jul 25, 2005) |
| Status | Terminated |
| Reason | Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating. |
| Root cause | Other |
| Action | Firm will be sending letters of caution to all users that reemphasizes labeling beginning 7/25/2005. New software is being developed which will include a change to maintain STANDBY coolant temperature regulation indefinitely, removing any risk of failure. |
| Quantity | 207 |
| Distribution | Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, |
| FDA record | Open on fda.gov |