BEUDAMED
    FDA Recall Terminated

    SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. Used to facilitate the delivery of defined radiotherapy treatment plans.

    Recall: Z-1515-2008 · Initiated February 14, 2008

    Recall

    Recall Number
    Z-1515-2008
    Event Number
    46941
    Firm
    Impac Medical Systems Inc
    FEI Number
    1000123805
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2008
    Posted
    August 16, 2008
    Terminated
    June 24, 2009
    Address
    100 Mathilda Pl, Fl 5th, Sunnyvale, CA, 94086-6076

    Description

    SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. Used to facilitate the delivery of defined radiotherapy treatment plans.

    Reason

    Software issue may result in change to intended treatment field, potentially resulting in mistreatment.

    Action

    Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.

    Distribution

    Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.

    Quantity

    36 units