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    XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code muj·September 10, 2010

    Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·October 31, 2011

    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·May 22, 2013

    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·April 25, 2014

    Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·November 16, 2010

    Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above. Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·January 19, 2009

    ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·December 11, 2009

    Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·May 10, 2010

    Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability to edit and modify patient data from a Windows-based PC and transfer the information back to the RTP system.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·November 30, 2007

    HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

    FDA Recall
    Terminated ·Accuray Incorporated·Product code MUJ·July 13, 2011

    Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 9, 2012

    Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code MUJ·November 18, 2013

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Recall
    Terminated ·Brainlab AG Kapellenstr. 12 Feldkirchen Germany·Product code MUJ·November 5, 2015

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·March 4, 2015

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code MUJ·August 16, 2021

    RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

    RayStation 14.0.0.3338. Radiation Therapy Treatment Planning System.

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

    RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·March 28, 2024

    RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·February 23, 2024