Alsius Corporation Alsius CoolGard 3000 Temperature Regulation System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alsius CoolGard 3000 Temperature Regulation System
Brand
Alsius Corporation
Lot Codes / Batch Numbers
All units manufactured before April 12, 2005.
Products Sold
All units manufactured before April 12, 2005.
Alsius Corporation is recalling Alsius CoolGard 3000 Temperature Regulation System due to 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 bein. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026