Date Initiated by Firm |
November 10, 2004 |
Date Posted |
November 25, 2004 |
Recall Status1 |
Terminated 3 on January 12, 2005 |
Recall Number |
Z-0258-05 |
Recall Event ID |
30412 |
510(K)Number |
K030421 K014241
|
Product Classification |
System, Hypothermia, Intravenous, Cooling - Product Code NCX
|
Product |
Alsius CoolGard 3000 patient temperature regulation system |
Code Information |
Serial numbers 30000160 and 30000132 |
Recalling Firm/ Manufacturer |
Alsius Corporation 15770 Laguna Canyon Rd Ste 150 Irvine CA 92618-3111
|
For Additional Information Contact |
Kenneth Collins 949-453-0150
|
Manufacturer Reason for Recall |
Product alarms that there may be a power supply interruption.
|
FDA Determined Cause 2 |
Other |
Action |
Firm removed products from use for repair on 11/10/2004. |
Quantity in Commerce |
2 |
Distribution |
IL and NC.
Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NCX and Original Applicant = ALSIUS CORP.
|