BEUDAMED
    FDA Recall Terminated

    Focal Sim radiation therapy treatment planning system

    Recall: Z-1244-2015 · Initiated December 19, 2014

    Recall

    Recall Number
    Z-1244-2015
    Event Number
    70433
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 19, 2014
    Posted
    March 4, 2015
    Terminated
    August 7, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Focal Sim radiation therapy treatment planning system

    Reason

    Incorrect CT to ED when using the Monaco Image Statistics Tool.

    Action

    An Important User Notice (IUN 382-03-FCL-001) was issued to customers on 12/19/2014. The notice included a workaround to be used until a new software release. The notice also included an acknowledgement form to be returned.

    Distribution

    Worldwide distribution. US nationwide (AL, AK, CA, CO, CT, FL, IL, IN, LA, MD, MA, MI, MO, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WY, DC), Puerto Rico, Argentina, Austria, Australia, Bulgaria, Bahrain, Brazil, Belarus, Canada, Chile, China, Colombia, Cuba, Cyprus, Czech Republic, Germany, Algeria, Egypt, Spain, France, Great Britain, Greece, Croatia, Indonesia, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Sri Lanka, Lithuania, Libya, Morocco, Macedonia, Mexico, Malaysia, New Zealand, Philippines, Portugal, Romania, Serbia, Russia, Singapore, Slovenia, Suriname, Thailand, Turkey, Ukraine, Venezuela, South Africa, Kosovo.

    Quantity

    907