Z-0258-05

Alsius CoolGard 3000 patient temperature regulation system

Name: Z-0258-05 Alsius CoolGard 3000 patient temperature regulation system
Creator: Alsius Corporation
Published: 2004-11-10
License: https://open.fda.gov/license/

Alsius Corp. / initiated 2004-11-10 / Terminated

FDA source

Alsius Corporation began a recall of Alsius CoolGard 3000 patient temperature regulation system on 2004-11-10. The reason FDA records is "Product alarms that there may be a power supply interruption". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0258-05
Status: Terminated
Initiated: 2004-11-10
Posted: 2004-11-25
Terminated: 2005-01-12
Recalling firm: Alsius Corp.
Product: Alsius CoolGard 3000 patient temperature regulation system
Product code: NCX System, Hypothermia, Intravenous, Cooling
Reason for recall: Product alarms that there may be a power supply interruption.
FDA root cause: Other
Action: Firm removed products from use for repair on 11/10/2004.
Quantity in commerce: 2
Distribution: IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
Product codes and lots: Serial numbers 30000160 and 30000132

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)