Alsius CoolGard 3000 patient temperature regulation system recallZ-0258-05 · Alsius Corporation · initiated Nov 10, 2004
Terminated All recalls posted in November 2004
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
Product alarms that there may be a power supply interruption.
FDA root cause category: Other
What the company is doing
Firm removed products from use for repair on 11/10/2004.
Recall details
- Recall number
- Z-0258-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 10, 2004
- Posted by the FDA
- Nov 25, 2004
- Recalling firm
- Alsius Corporation
- Quantity
- 2
- Product code
- NCX
- FDA submissions
- K014241, K030421
- Distribution
- IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
Product description
Alsius CoolGard 3000 patient temperature regulation system
Code information (models, lots, serial numbers)
Serial numbers 30000160 and 30000132
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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