Brand

Elekta, Inc. Recalls

78 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Elekta, Inc..

78Total Recalls
0Critical
39,015Units Affected
Mar 19, 2026Most Recent
All Recalls

Every Elekta, Inc. Recall

Sorted by most recent. Click any recall for full details.

78 recalls
High RiskFDA
Elekta, Inc.
Brand Name: Leksell Vantage Arc System REF: 1053958
Medical Devices·768 affected·Mar 19, 2026
High RiskFDA
Elekta, Inc.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ ...
Medical Devices·352 affected·Feb 18, 2026
High RiskFDA
Elekta, Inc.
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description...
Medical Devices·0 affected·Dec 12, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Medical Devices·1 affected·Dec 10, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·64 affected·Jan 15, 2025
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator...
Medical Devices·291 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·264 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·451 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·47 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·1,019 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·315 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Medical Devices·46 affected·May 5, 2023
High RiskFDA
Elekta Inc
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,020 affected·Feb 28, 2023
High RiskFDA
Elekta, Inc.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Medical Devices·1,072 affected·Oct 13, 2021
High RiskFDA
Elekta, Inc.
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c...
Medical Devices·4,405 affected·Sep 17, 2021
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·31 affected·Sep 2, 2021
High RiskFDA
Elekta, Inc.
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Medical Devices·40 affected·Apr 20, 2021
High RiskFDA
Elekta, Inc.
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments an...
Medical Devices·32 affected·Apr 30, 2020
High RiskFDA
Elekta Inc
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Medical Devices·25 affected·Mar 30, 2020
High RiskFDA
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System
Medical Devices·21 affected·Dec 18, 2019
High RiskFDA
Elekta Inc
Monaco Radiation Treatment Planning System (RTP) System
Medical Devices·76 affected·Nov 22, 2019
High RiskFDA
Elekta Inc
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans fo...
Medical Devices·49 affected·Sep 4, 2019
High RiskFDA
Elekta Inc
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans f...
Medical Devices·30 affected·Sep 4, 2019
High RiskFDA
Elekta, Inc.
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy t...
Medical Devices·12 affected·Jun 24, 2019
High RiskFDA
Elekta, Inc.
Monaco Radiation Treatment Planning (RTP) System
Medical Devices·14 affected·Feb 8, 2019
High RiskFDA
Elekta, Inc.
MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment plan...
Medical Devices·3,950 affected·Dec 13, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment pla...
Medical Devices·551 affected·Dec 4, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·185 affected·Aug 3, 2018
High RiskFDA
Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Inf...
Medical Devices·2,998 affected·Dec 1, 2017
High RiskFDA
Elekta, Inc.
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target ...
Surgical Devices·2 affected·May 23, 2017
High RiskFDA
Elekta, Inc.
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan ra...
Medical Devices·433 affected·Dec 23, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·279 affected·Dec 21, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports informati...
Medical Devices·47 affected·Dec 2, 2016
High RiskFDA
Elekta, Inc.
Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,148 affected·Nov 17, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·671 affected·Nov 3, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy....
Medical Devices·365 affected·Sep 29, 2016
High RiskFDA
Elekta, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of...
Medical Devices·13 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·3,012 affected·Aug 18, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·383 affected·Jul 15, 2016
High RiskFDA
Elekta, Inc.
Medical Linear Accelerator
Medical Devices·553 affected·Jul 8, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·69 affected·Jun 17, 2016
High RiskFDA
Elekta, Inc.
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Medical Devices·20 affected·May 12, 2016
High RiskFDA
Elekta, Inc.
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head struct...
Medical Devices·217 affected·Apr 19, 2016
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delive...
Medical Devices·399 affected·Dec 9, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Medical Devices·211 affected·Nov 24, 2015
High RiskFDA
Elekta, Inc.
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·154 affected·Oct 16, 2015
High RiskFDA
Elekta, Inc.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy ...
Medical Devices·1,440 affected·Aug 31, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery...
Medical Devices·74 affected·Jul 1, 2015