BEUDAMED
    FDA Recall Terminated

    EZ-DOP, diagnostic ultrasound imaging system

    Recall: Z-0885-04 · Initiated January 5, 2004

    Recall

    Recall Number
    Z-0885-04
    Event Number
    28472
    Firm
    DWL Systems, Inc.
    FEI Number
    3003504574
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2004
    Posted
    July 20, 2004
    Terminated
    September 10, 2004
    Address
    100 Carpenter Drive, Suite 202, Sterling, VA, 20164

    Description

    EZ-DOP, diagnostic ultrasound imaging system

    Reason

    A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.

    Action

    The firm notified consignees by mail on 1/5/2004 and advised of potential for inaccurate power display when the device is actually transmitting. Consignees were requested to return the device for a software upgrade.

    Distribution

    Units were distributed to end users worldwide including 67 domestic consignees.

    Quantity

    367 units