Alsius CoolGard 3000 Temperature Regulation System recallZ-1397-05 · Alsius Corporation · initiated Jul 25, 2005
Terminated All recalls posted in August 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alsius Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1397-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 25, 2005
- Posted by the FDA
- Aug 24, 2005
- Recalling firm
- Alsius Corporation
- Quantity
- 207
- Product code
- NCX
- FDA submissions
- K014241, K030421
- Distribution
- Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
Product description
Alsius CoolGard 3000 Temperature Regulation System
Code information (models, lots, serial numbers)
All units manufactured before April 12, 2005.
Other devices under the same FDA submission
2 devices cleared under K014241, K030421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Start-Up Kit CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling8 reports
- Start-Up Kit Custom Luer CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling1 death4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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