BEUDAMED
    FDA Recall Terminated

    Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

    Recall: Z-0379-2007 · Initiated May 23, 2006

    Recall

    Recall Number
    Z-0379-2007
    Event Number
    37099
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2006
    Posted
    February 10, 2007
    Terminated
    March 23, 2009
    Address
    1140 US Highway 22, Bridgewater, NJ, 08807-2958

    Description

    Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

    Reason

    The Connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the Servo-i Ventilator

    Action

    Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going

    Distribution

    Worldwide

    Quantity

    2,436 units