BEUDAMED
    FDA Recall Terminated

    Anestar Anesthesia Delivery System

    Recall: Z-1441-04 · Initiated June 24, 2003

    Recall

    Recall Number
    Z-1441-04
    Event Number
    29545
    Firm
    Datascope Corp
    FEI Number
    2221819
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2003
    Posted
    September 9, 2004
    Terminated
    October 3, 2006
    Address
    800 MacArthur Blvd, Mahwah, NJ, 07430-0619

    Description

    Anestar Anesthesia Delivery System

    Reason

    Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.

    Action

    A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.

    Distribution

    The units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.