Class 3 Device Recall

• Date Initiated by Firm: July 25, 2005
• Date Posted: August 24, 2005
• Recall Status: Terminated on January 31, 2007
• Recall Number: Z-1397-05
• Recall Event ID: 32762
• 510(K)Number: K014241 K030421
• 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: 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