BEUDAMED
    FDA Recall Terminated

    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

    Recall: Z-1307-2014 · Initiated February 6, 2014

    Recall

    Recall Number
    Z-1307-2014
    Event Number
    67504
    Firm
    RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    February 6, 2014
    Posted
    March 28, 2014
    Terminated
    February 17, 2017

    Description

    RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy.

    Reason

    Potential for dose errors due to software program errors.

    Action

    RaySearch Laboratories sent an Field Safety Notice, Medical Device Correction letter dated February 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. ACTIONS TO BE TAKEN BY THE USER A workaround that eliminates the described error is to select the discard rotations option in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. Another option is to use the ROI based deformable registration when applicable, as this functionality is not affected by the error. SOLUTION This issue will be resolved in a patch release of RayStation, scheduled for market release February 28, 2014. Release schedule is subject to regulatory approval for some markets. In the meantime, this field safety notice is being distributed to all customers. CONTACT INFORMATION For further information, please contact For the Americas: Customer Support, RaySearch Americas, at +1 877 778 3849 For Europe, Asia and rest of the world: RaySearch Laboratories AB, at +46 8 5450 6130 Thank you for your cooperation, and we apologize for any inconvenience

    Distribution

    Worldwide Distribution - US including the states of NY, OH, MD, CT, CO, TN, IL, AZ, MS, NJ, PA, DE, FL, CA and WA., and the countries of New Zealand, Australia, Republic of Korea, China, Italy, Germany, Norway, Belgium, Switzerland, United Kingdom and Spain.

    Quantity

    151 units Total (88 units domestically & 63 units internationally)