FDA Recall
Terminated
Alsius CoolGard 3000 patient temperature regulation system
Recall: Z-0258-05
·
Initiated November 10, 2004
Recall
- Recall Number
- Z-0258-05
- Event Number
- 30412
- Firm
- Alsius Corporation
- FEI Number
- 3002922896
- Product Code
- NCX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 10, 2004
- Posted
- November 25, 2004
- Terminated
- January 12, 2005
- Address
- 15770 Laguna Canyon Rd, Ste 150, Irvine, CA, 92618-3111
Description
Alsius CoolGard 3000 patient temperature regulation system
Reason
Product alarms that there may be a power supply interruption.
Action
Firm removed products from use for repair on 11/10/2004.
Distribution
IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
Quantity
2