BEUDAMED
    FDA Recall Terminated

    GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.

    Recall: Z-0113-2008 · Initiated July 6, 2007

    Recall

    Recall Number
    Z-0113-2008
    Event Number
    39400
    Firm
    Ge Healthcare
    FEI Number
    3005860720
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 6, 2007
    Posted
    November 7, 2007
    Terminated
    October 21, 2008
    Address
    9900 W Innovation Dr, Wauwatosa, WI, 53226-4856

    Description

    GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA.

    Reason

    When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

    Action

    GE Healthcare sent customer letters on July 15, 2007 to affected customers. The letter included a short term mitigation recommendation and a long-term correction. The long-term correction will be software upgrade provided free of charge to all affected customers.

    Distribution

    Nationwide.

    Quantity

    521 Units