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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm July 25, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on January 31, 2007
Recall Number Z-1397-05
Recall Event ID 32762
510(K)Number k030421  k014241  
Product Classification System, Hypothermia, Intravenous, Cooling - Product Code NCX
Product Alsius CoolGard 3000 Temperature Regulation System
Code Information All units manufactured before April 12, 2005.
Recalling Firm/
Manufacturer		 Alsius Corporation
15770 Laguna Canyon Rd Ste 150
Irvine CA 92618-3111
For Additional Information Contact Dr. Kenneth Collins
949-453-0150 Ext. 117
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 207
Distribution Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
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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