FDA Medical Device Recalls (openFDA)
Alsius Corporation: Alsius CoolGard 3000 Temperature Regulation System
- Recall number
- Z-1397-05
- Recalling firm
- Alsius Corporation
- Product
- Alsius CoolGard 3000 Temperature Regulation System
- Status
- Terminated
- Initiated
- 2005-07-25
- Posted
- 2005-08-24
- Terminated
- 2007-01-31
- 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,
- Lot, serial or model codes
- All units manufactured before April 12, 2005.
- 510(k) numbers
- ["K014241","K030421"]
- PMA numbers
- not on file
- Product code
- NCX
- Firm FEI
- 3002922896
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28