BEUDAMED
    FDA Enforcement Class II Terminated

    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

    Recall: Z-1944-2012 · Reported July 18, 2012

    Enforcement

    Recall Number
    Z-1944-2012
    Event ID
    62302
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Impac Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2012
    Initiation Date
    June 8, 2012
    Classification Date
    July 6, 2012
    Termination Date
    June 19, 2013
    Address
    100 Mathilda Place, 5th Floor, Sunnyvale, CA, 94086-6076, United States

    Description

    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086

    Reason

    Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.

    Code Info

    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.

    Distribution

    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.

    Quantity

    11 affected sites