Elekta, Inc.
78 recalls on record · Latest: Jan 21, 2026
FDA Devices Moderate Jan 21, 2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Devices Moderate Feb 19, 2025
MOSAIQ Oncology Information System
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Dec 13, 2023
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Devices Moderate Jun 7, 2023
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
FDA Devices Moderate Mar 15, 2023
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Nov 3, 2021
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
FDA Devices Moderate Oct 20, 2021
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Syn…
FDA Devices Moderate Oct 6, 2021
MOSAIQ Oncology Information System
FDA Devices Moderate Jun 9, 2021
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
FDA Devices Moderate Jul 8, 2020
Elekta Unity, Image-Guided Radiation Therapy System
FDA Devices Moderate Jun 17, 2020
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotact…
FDA Devices Moderate May 6, 2020
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Devices Moderate May 6, 2020
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients…
FDA Devices Moderate Dec 18, 2019
Monaco Radiation Treatment Planning System (RTP) System
FDA Devices Moderate Oct 2, 2019
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients w…
FDA Devices Moderate Oct 2, 2019
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients …
FDA Devices Moderate Jul 24, 2019
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments an…
FDA Devices Moderate Mar 6, 2019
Monaco Radiation Treatment Planning (RTP) System
FDA Devices Moderate Feb 20, 2019
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and del…
FDA Devices Moderate Jan 2, 2019
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and de…
FDA Devices Moderate Aug 29, 2018
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axess…
FDA Devices Moderate Aug 29, 2018
MOSAIQ Oncology Information System
FDA Devices Moderate Jul 19, 2017
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a f…
FDA Devices Moderate Jan 18, 2017
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Jan 18, 2017
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation trea…
FDA Devices Moderate Dec 21, 2016
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow amon…
FDA Devices Moderate Dec 7, 2016
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Dec 7, 2016
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Oct 19, 2016
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system …
FDA Devices Moderate Sep 14, 2016
Medical Linear Accelerator
FDA Devices Moderate Sep 7, 2016
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracki…
FDA Devices Moderate Sep 7, 2016
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Aug 3, 2016
MOSAIQ Oncology Information System
FDA Devices Moderate Jul 6, 2016
MOSAIQ Oncology Information System
FDA Devices Moderate Jun 1, 2016
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Devices Moderate May 4, 2016
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging…
FDA Devices Moderate Jan 6, 2016
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It suppo…
FDA Devices Moderate Dec 23, 2015
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
FDA Devices Moderate Nov 4, 2015
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Oct 28, 2015
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachythe…
FDA Devices Moderate Jul 22, 2015
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It support…
FDA Devices Moderate Mar 25, 2015
Elekta Precise Treatment Table
FDA Devices Moderate Feb 18, 2015
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed med…
FDA Devices Moderate Nov 26, 2014
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports informati…
FDA Devices Moderate Nov 5, 2014