BEUDAMED
    FDA Recall Terminated

    ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.

    Recall: Z-1146-2007 · Initiated April 7, 2006

    Recall

    Recall Number
    Z-1146-2007
    Event Number
    38355
    Firm
    Northwest Medical Physics Equipment Inc
    FEI Number
    1000126033
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 7, 2006
    Posted
    August 8, 2007
    Terminated
    April 19, 2011
    Address
    1910 120th Pl SE, Suite 101, Everett, WA, 98208

    Description

    ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.

    Reason

    This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.

    Action

    Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.

    Distribution

    Customers in USA, Korea, Spain and UK.

    Quantity

    141 copies