BEUDAMED
    FDA Enforcement Class II Terminated

    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

    Recall: Z-1308-2014 · Reported April 9, 2014

    Enforcement

    Recall Number
    Z-1308-2014
    Event ID
    67511
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 9, 2014
    Initiation Date
    February 6, 2014
    Classification Date
    March 31, 2014
    Termination Date
    February 17, 2017
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software

    Reason

    RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.

    Code Info

    Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses

    Distribution

    OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,

    Quantity

    19 units (16 units domestically & 3 units internationally)