Z-1397-05

Alsius CoolGard 3000 Temperature Regulation System

Name: Z-1397-05 Alsius CoolGard 3000 Temperature Regulation System
Creator: Alsius Corporation
Published: 2005-07-25
License: https://open.fda.gov/license/

Alsius Corp. / initiated 2005-07-25 / Terminated

FDA source

Alsius Corporation began a recall of Alsius CoolGard 3000 Temperature Regulation System on 2005-07-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1397-05
Status: Terminated
Initiated: 2005-07-25
Posted: 2005-08-24
Terminated: 2007-01-31
Recalling firm: Alsius Corp.
Product: Alsius CoolGard 3000 Temperature Regulation System
Product code: NCX System, Hypothermia, Intravenous, Cooling
Reason for recall: 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: 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 in commerce: 207
Distribution: Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
Product codes and lots: All units manufactured before April 12, 2005.

Product code NCX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)