BEUDAMED
    FDA Recall Terminated

    Alsius CoolGard Temperature Regulation System

    Recall: Z-0369-06 · Initiated November 9, 2005

    Recall

    Recall Number
    Z-0369-06
    Event Number
    34073
    Firm
    Alsius Corporation
    FEI Number
    3002922896
    Product Code
    NCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 9, 2005
    Posted
    January 10, 2006
    Terminated
    February 5, 2007
    Address
    15770 Laguna Canyon Rd, Ste 150, Irvine, CA, 92618-3111

    Description

    Alsius CoolGard Temperature Regulation System

    Reason

    Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.

    Action

    Alsius Corporation is notifying customers of an issue requiring service of their CoolGard 3000 by letter shipped via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt.

    Distribution

    Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom

    Quantity

    239