Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
FDA device recall Z-1159-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Alsius Corporation
- Reason for recall
- Higher than expected rate of pump alarms occur under specific conditions.
- Action taken
- Firm replaced circuit board having a new resistor. Recall is complete.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 15
- Distribution
- MA, PA, VA, FL, AL, MO, TX
- Date initiated
- 2004-06-21
- Date posted
- 2004-07-23
- Date terminated
- 2004-12-02
- 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 |