Alsius CoolGard 3000 patient temperature regulation system
FDA device recall Z-0258-05 · posted 2004-11-25 · Terminated
Recall details
- Recalling firm
- Alsius Corporation
- Reason for recall
- Product alarms that there may be a power supply interruption.
- Action taken
- Firm removed products from use for repair on 11/10/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 2
- Distribution
- IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC.
- Date initiated
- 2004-11-10
- Date posted
- 2004-11-25
- Date terminated
- 2005-01-12
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (K030421) | Alsius Corp. | 2003-10-23 |
| COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (K014241) | Alsius Corp. | 2003-08-01 |