Elekta recalls
Elekta appears in 122 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-15.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Flet…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for c…
FDA Device · Class II · 2026-07-15 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2026-06-17 · Elekta - Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Device · Class II · 2026-05-06 · Elekta - Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
FDA Device · Class II · 2026-03-25 · Elekta - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell G…
FDA Device · Class II · 2026-02-18 · Elekta - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Lek…
FDA Device · Class II · 2026-02-18 · Elekta - Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A…
FDA Device · Class II · 2026-02-04 · Elekta - MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Device · Class II · 2026-01-21 · Elekta - Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The In…
FDA Device · Class II · 2025-11-12 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2025-02-19 · Elekta - ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA LIMITED Versa HD, REF XRT 2121, 2131
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA AXESSE, REF XRT 2181, XRT 27891
FDA Device · Class II · 2023-12-13 · Elekta - ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511
FDA Device · Class II · 2023-12-13 · Elekta - Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil
FDA Device · Class II · 2023-06-14 · Elekta - Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity
FDA Device · Class II · 2023-06-07 · Elekta - Monaco RTP System
FDA Device · Class II · 2023-03-15 · Elekta - Oncentra Brachy radiation therapy planning system software
FDA Device · Class II · 2022-12-21 · Elekta - Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
FDA Device · Class II · 2021-11-03 · Elekta - Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator
FDA Device · Class II · 2021-10-20 · Elekta - Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2021-10-06 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2021-10-06 · Elekta - Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
FDA Device · Class II · 2021-09-08 · Elekta - Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
FDA Device · Class II · 2021-06-09 · Elekta - Elekta Unity, Image-Guided Radiation Therapy System
FDA Device · Class II · 2020-07-08 · Elekta - Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and…
FDA Device · Class II · 2020-06-17 · Elekta - Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
FDA Device · Class II · 2020-06-17 · Elekta - Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans fo…
FDA Device · Class II · 2020-05-06 · Elekta - Leksell Vantage Stereotactic System
FDA Device · Class II · 2020-05-06 · Elekta - Monaco Radiation Treatment Planning System (RTP) System
FDA Device · Class II · 2019-12-18 · Elekta - Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pati…
FDA Device · Class II · 2019-10-02 · Elekta - Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for pat…
FDA Device · Class II · 2019-10-02 · Elekta - Monaco Radiation Treatment Planning System (RTP) System
FDA Device · Class II · 2019-09-04 · Elekta - iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
FDA Device · Class II · 2019-08-21 · Elekta - Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
FDA Device · Class II · 2019-08-07 · Elekta - Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatm…
FDA Device · Class II · 2019-07-24 · Elekta - Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereot…
FDA Device · Class II · 2019-05-15 · Elekta - Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation…
FDA Device · Class II · 2019-04-17 · Elekta - Monaco Radiation Treatment Planning (RTP) System
FDA Device · Class II · 2019-03-06 · Elekta - MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning…
FDA Device · Class II · 2019-02-20 · Elekta - Elekta Unity
FDA Device · Class II · 2019-01-16 · Elekta - MOSAIQ Oncology Information System Version 2.64
FDA Device · Class II · 2019-01-02 · Elekta - ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infin…
FDA Device · Class II · 2018-08-29 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2018-08-29 · Elekta - HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system
FDA Device · Class II · 2018-08-01 · Elekta - Integrity R1.2
FDA Device · Class II · 2018-03-07 · Elekta