BEUDAMED
    FDA Recall Terminated

    Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

    Recall: Z-0589-2010 · Initiated November 17, 2009

    Recall

    Recall Number
    Z-0589-2010
    Event Number
    53843
    Firm
    MAQUET Inc.
    FEI Number
    3008355164
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 17, 2009
    Posted
    January 5, 2010
    Terminated
    June 4, 2012
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470

    Description

    Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

    Reason

    Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.

    Action

    Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.

    Distribution

    Worldwide distribution

    Quantity

    29364 (8438 of those in US)