Alsius CoolGard 3000 Temperature Regulation System
FDA device recall Z-1397-05 · posted 2005-08-24 · Terminated
Recall details
- Recalling firm
- Alsius Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 207
- Distribution
- Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
- Date initiated
- 2005-07-25
- Date posted
- 2005-08-24
- Date terminated
- 2007-01-31
- 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 |