Elekta, Inc.
Atlanta, GA
This page shows every FDA and USDA recall linked to Elekta, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
93
Total Recalls
2012
First Recall
2026
Most Recent
Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11,3,...
Feb 10, 2026
· Device
Open, Classified
Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11.1
P...
Feb 10, 2026
· Device
Open, Classified
Brand Name: Elekta Medical Linear Accelerator
Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, V...
Jan 23, 2026
· Device
Open, Classified
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Jan 13, 2026
· Device
Open, Classified
Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software Version: n/...
Nov 5, 2025
· Device
Open, Classified
MOSAIQ Oncology Information System
Feb 12, 2025
· Device
Open, Classified
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accel...
Dec 1, 2023
· Device
Open, Classified
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Dec 1, 2023
· Device
Open, Classified
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Li...
Dec 1, 2023
· Device
Open, Classified
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy...
Dec 1, 2023
· Device
Open, Classified
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation...
Dec 1, 2023
· Device
Open, Classified
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sys...
Dec 1, 2023
· Device
Open, Classified
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Jun 2, 2023
· Device
Open, Classified
Elekta Medical Linear Accelerator (ELMA) included in the below platforms:
a. Elekta Infinity;
b. Versa HD;...
May 30, 2023
· Device
Open, Classified
Oncentra Brachy radiation therapy planning system software.
Dec 15, 2022
· Device
Open, Classified
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Oct 13, 2021
· Device
Open, Classified
Elekta Medical Linear Accelerator (EMLA), configured as follows:
a. Elekta Precise Digital Accelerator;...
Sep 17, 2021
· Device
Terminated
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic...
Apr 20, 2021
· Device
Terminated
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radi...
Jun 5, 2020
· Device
Terminated
Elekta Unity, Image-Guided Radiation Therapy System
Dec 18, 2019
· Device
Terminated
Monaco Radiation Treatment Planning System (RTP) System
Aug 23, 2019
· Device
Terminated
Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity using Magnetic Resonance Imaging is indicate...
Jul 16, 2019
· Device
Terminated
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Jun 19, 2019
· Device
Terminated
Monaco Radiation Treatment Planning (RTP) System
Feb 8, 2019
· Device
Terminated
MOSAIQ Oncology Information System and Sequencer
MOSAIQ is an oncology information system used to manage work...
Dec 13, 2018
· Device
Open, Classified
MOSAIQ Oncology Information System Version 2.64.
MOSAIQ is an oncology information system used to manage wo...
Dec 4, 2018
· Device
Completed
MOSAIQ Oncology Information System
Aug 3, 2018
· Device
Terminated
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system.
Prod...
May 16, 2018
· Device
Terminated
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Preci...
Dec 1, 2017
· Device
Terminated
MOSAIQ Medical Charged-Particle Radiation Therapy System
Jun 30, 2017
· Device
Terminated
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher
Product Usage:
MOSAIQ is an oncology infor...
Jun 21, 2017
· Device
Terminated
iGUIDE Software 2.2
Product Usage:
Control of accurate patient positioning with assistance of a 30 Tracking...
Jun 19, 2017
· Device
Terminated
Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures rang...
May 31, 2017
· Device
Terminated
Monaco RTP System.
Used to make treatment plans for patients with prescriptions for external beam radiation t...
Jan 10, 2017
· Device
Terminated
Oncentra External Beam Oncentra Brachy
Product Usage:
Oncentra is radiation therapy planning software designe...
Dec 23, 2016
· Device
Terminated
Monaco RTP System
Product Usage:
Used to make treatment plans for patients with prescriptions for external be...
Dec 21, 2016
· Device
Terminated
MOSAIQ Oncology Information System
The product is used to manage workflows for treatment planning and delive...
Dec 2, 2016
· Device
Terminated
Monaco TRP System
The Monaco system is used to make treatment plans for patients with prescriptions for extern...
Nov 17, 2016
· Device
Terminated
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation th...
Nov 3, 2016
· Device
Terminated
Monaco RTP System
The Monaco system is used to make treatment plans for patients with prescriptions for extern...
Sep 29, 2016
· Device
Terminated
HexaPOD evo RT System
Product Usage:
The intended use of the device is the control of accurate patient positi...
Aug 30, 2016
· Device
Terminated
Monaco RTP System
Used to make treatment plans for patients with prescriptions for external beam radiation th...
Aug 18, 2016
· Device
Terminated
MOSAIQ Oncology Information System
Jul 15, 2016
· Device
Open, Classified
Medical Linear Accelerator
Jul 8, 2016
· Device
Terminated
MOSAIQ Oncology Information System
Jun 17, 2016
· Device
Terminated
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
May 23, 2016
· Device
Terminated
Monaco RTP System
Product Usage:
The Monaco system is used to make treatment plans for patients with prescrip...
May 18, 2016
· Device
Terminated
Radionuclide Radiation Therapy System
Product The product is a teletherapy device intended for stereotactic i...
Apr 19, 2016
· Device
Terminated
Oncentra External Beam - VMAT - Radiation therapy planning system
Product Usage: The Oncentra system is a ra...
Dec 18, 2015
· Device
Terminated
MOSAIQ Oncology Information System
MOSAIQ is an oncology information system used to manage workflows for trea...
Dec 9, 2015
· Device
Terminated