BEUDAMED
    FDA Recall Terminated

    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

    Recall: Z-2277-2013 · Initiated May 22, 2013

    Recall

    Recall Number
    Z-2277-2013
    Event Number
    65998
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 22, 2013
    Posted
    September 25, 2013
    Terminated
    December 23, 2013
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

    Reason

    Patient needs to be positioned as indicated by the treatment plan.

    Action

    Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.

    Distribution

    Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.

    Quantity

    72