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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 21, 2004
Date Posted July 23, 2004
Recall Status1 Terminated 3 on December 02, 2004
Recall Number Z-1159-04
Recall Event ID 29538
510(K)Number k030421  k014241  
Product Classification System, Hypothermia, Intravenous, Cooling - Product Code NCX
Product Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Code Information All codes.
Recalling Firm/
Manufacturer		 Alsius Corporation
15770 Laguna Canyon Rd Ste 150
Irvine CA 92618-3111
For Additional Information Contact Dr. Kenneth A. Collins
949-453-0150
Manufacturer Reason
for Recall		 Higher than expected rate of pump alarms occur under specific conditions.
FDA Determined
Cause 2		 Other
Action Firm replaced circuit board having a new resistor. Recall is complete.
Quantity in Commerce 15
Distribution MA, PA, VA, FL, AL, MO, TX
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.
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