BEUDAMED
    FDA Recall Terminated

    RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.

    Recall: Z-1481-2014 · Initiated February 14, 2014

    Recall

    Recall Number
    Z-1481-2014
    Event Number
    67535
    Firm
    RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 14, 2014
    Posted
    April 21, 2014
    Terminated
    February 15, 2017

    Description

    RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.

    Reason

    RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.

    Action

    RaySearch Laboratories sent a Field Safety Notice, Medical Device Correction letter dated February 14, 2014 to their customers via email. The letter identified the affected product, problem and actions to be taken by the user. Customers with questions may contact Freddie Cardel, Director of Customer Support at 1-877-778-3849 or via email at [email protected].

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.

    Quantity

    251 units (148 units domestically & 103 units internationally)