BEUDAMED
    FDA Recall Terminated

    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Recall: Z-2712-2016 · Initiated August 18, 2016

    Recall

    Recall Number
    Z-2712-2016
    Event Number
    74961
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 18, 2016
    Terminated
    February 28, 2025
    Address
    400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

    Description

    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    Reason

    In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

    Action

    Important User Notice 382-03-MON-003 was sent to customers on August 18, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The letter also states that the problem will be in a future Monaco release. The customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta as soon as possible but no longer than 30 days from receipt. Questions can be directed to the local Elekta office.

    Distribution

    Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.

    Quantity

    3,012 units