BEUDAMED
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    Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·May 30, 2007

    Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 6, 2009

    Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·December 12, 2008

    Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·November 9, 2008

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

    FDA Recall
    Terminated ·Elekta Inc·Product code HAW·March 30, 2020

    Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·May 25, 2011

    XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·May 19, 2010

    Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IWB·October 1, 2007

    Elekta VBH Head FIX The VBH HeadFIX is intended for positioning and immobilization of the head and neck, stereotactic diagnostic localization and stereotactic radiotherapy of cranial targets.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·October 14, 2010

    FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·August 18, 2014

    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·February 17, 2014

    Monaco Radiation Treatment Planning System (RTP) System

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·August 23, 2019

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 20, 2012

    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

    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

    XiO Radiation Treatment Planning System, XiO Release 4.0.2 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·May 28, 2010

    iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·June 19, 2019

    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

    Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the process of patient treatment on a radiotherapy treatment machine. Sequencer provides the capability to notify the user of actions that need to take place prior to treatment, to display reference images for set up purposed and to auto setup the machine to predefined settings. The actual settings are read from the treatment machine, via the machines communication interface, and compared to predefined values. if a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate points during the treatment, the actual delivered values are recorded to provide treatment tracking.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·September 9, 2011