BEUDAMED
    FDA Recall Terminated

    Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

    Recall: Z-1159-04 · Initiated June 21, 2004

    Recall

    Recall Number
    Z-1159-04
    Event Number
    29538
    Firm
    Alsius Corporation
    FEI Number
    3002922896
    Product Code
    NCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 21, 2004
    Posted
    July 23, 2004
    Terminated
    December 2, 2004
    Address
    15770 Laguna Canyon Rd, Ste 150, Irvine, CA, 92618-3111

    Description

    Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

    Reason

    Higher than expected rate of pump alarms occur under specific conditions.

    Action

    Firm replaced circuit board having a new resistor. Recall is complete.

    Distribution

    MA, PA, VA, FL, AL, MO, TX

    Quantity

    15