BEUDAMED
    FDA Recall Terminated

    The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.

    Recall: Z-0478-2011 · Initiated August 13, 2010

    Recall

    Recall Number
    Z-0478-2011
    Event Number
    56428
    Firm
    Sonosite, Inc.
    FEI Number
    3002087856
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 13, 2010
    Posted
    November 26, 2010
    Terminated
    July 21, 2011
    Address
    21919 30th Dr Se, Bothell, WA, 98021-3904

    Description

    The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.

    Reason

    Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect.

    Action

    Sonosite issued Urgent Medical Device Correction letters dated August 9, 2010 to consignees. Consignees were advised of the software problem and given directions to verify the software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a free software upgrade.

    Distribution

    Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.

    Quantity

    69