BEUDAMED
    FDA Recall Terminated

    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.

    Recall: Z-1084-2014 · Initiated November 25, 2013

    Recall

    Recall Number
    Z-1084-2014
    Event Number
    67184
    Firm
    Elekta, Inc.
    FEI Number
    1037831
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 25, 2013
    Posted
    March 6, 2014
    Terminated
    November 8, 2017
    Address
    400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227

    Description

    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.

    Reason

    During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.

    Action

    Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 043 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Corrective Action #2 - Permanent Solution - All users of Integrity 3.1 software will be informed or a mandatory upgrade to Integrity 3.2 upon its release which will prevent calibration from being inverted. Target Release for Integrity 3.2 will be available at the end of February 2014.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.

    Quantity

    300