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    Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The

    FDA Recall
    Open, Classified ·Elekta Inc·Product code MUJ·April 16, 2020

    MOSAIQ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·December 13, 2018

    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

    FDA Recall
    Open, Classified ·Elekta Inc·Product code MUJ·July 3, 2019

    Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

    FDA Recall
    Open, Classified ·Elekta Inc·Product code MUJ·September 4, 2019

    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·April 6, 2023

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·October 25, 2023

    MOSAIQ Oncology Information System

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·September 2, 2021

    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

    FDA Recall
    Open, Classified ·Elekta Inc·Product code MUJ·July 26, 2021

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·October 25, 2023

    MOSAIQ Oncology Information System

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·January 15, 2025

    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·December 14, 2025

    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code MUJ·December 12, 2025

    Brand Name: Leksell Vantage Arc System REF: 1053958

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code HAW·March 19, 2026

    Oncentra Brachy radiation therapy planning system software.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code MUJ·December 5, 2022

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·May 5, 2023

    MOSAIQ Oncology Information System

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·May 21, 2026

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·October 25, 2023

    Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code HAW·September 30, 2025

    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·December 10, 2025

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Recall
    Open, Classified ·Elekta, Inc.·Product code IYE·October 25, 2023