BEUDAMED
    FDA Recall Terminated

    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.

    Recall: Z-0159-2011 · Initiated February 19, 2010

    Recall

    Recall Number
    Z-0159-2011
    Event Number
    55712
    Firm
    Impac Medical Systems Inc
    FEI Number
    1000123805
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    February 19, 2010
    Posted
    October 28, 2010
    Terminated
    March 28, 2011
    Address
    100 Mathilda Pl, Fl 5th, Sunnyvale, CA, 94086-6076

    Description

    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.

    Reason

    Mistreatment-- The database conversion utility used during the upgrade errantly changes the start gantry angle to zero. Any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.

    Action

    ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email [email protected] or call their support center.

    Distribution

    Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy

    Quantity

    19 units.