Elekta, Inc.
116 recalls on record · Latest: Jul 15, 2026
Subscribe to new Elekta, Inc. recalls (RSS)
Agency notice ledger
Federal filing book Elekta, Inc. HEAVY-BOOK · SINGLE-AGENCY
#138 of 14,151 · 116 notices · 0.111% archive
- BOOK 116 notices
- RANK #138 of 14,151
- SHARE 0.111% archive
- AGENCY FDA Devices (116)
- CAT medical devices
- CATS 1 category
- LATEST Jul 15, 2026
- PHOTO Medtronic Perfusion S…
Nearest notice-volume peer: Medtronic Perfusion Systems (0 notice gap)
Elekta, Inc. accounts for about 0.111% of the 104,423-notice archive on 116 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Elekta, Inc.'s standing among 14,151 recalling firms
Elekta, Inc. ranks 138th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Elekta, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
116 138th of 14151 higher than 14,012 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Elekta, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Snoqualmie Go…
Snoqualmie Gourmet Ice Cream
117 notices
- Elekta, Inc. (this)
Elekta, Inc.
116 notices
- Medtronic Per…
Medtronic Perfusion Systems
116 notices
- Mitsubishi
Mitsubishi
115 notices
- Numbskull LLC
Numbskull LLC
115 notices
- Raysearch Lab…
Raysearch Laboratories Ab
115 notices
What this shows Elekta, Inc. holds about 0.111% of archive notices alongside 116 distinct filings.
FDA Devices Moderate Jul 15, 2026
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
FDA Devices Moderate Jul 15, 2026
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
FDA Devices Moderate Jul 15, 2026
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
FDA Devices Moderate Jun 17, 2026
MOSAIQ Oncology Information System
FDA Devices Moderate May 6, 2026
Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Devices Moderate Mar 25, 2026
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
FDA Devices Moderate Feb 18, 2026
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 Devices Moderate Feb 18, 2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
FDA Devices Moderate Feb 4, 2026
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 Devices Moderate Jan 21, 2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
FDA Devices Moderate Nov 12, 2025
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 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 14, 2023
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
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 Dec 21, 2022
Oncentra Brachy radiation therapy planning system software.
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 Synergy; d. Elekta Infinity; e. Versa HD
FDA Devices Moderate Oct 6, 2021
MOSAIQ Oncology Information System
FDA Devices Moderate Oct 6, 2021
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Devices Moderate Sep 8, 2021
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
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 stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
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 with prescriptions for external beam radiation therapy. The
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 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 planni
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 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 plann
FDA Devices Moderate Sep 4, 2019
Monaco Radiation Treatment Planning System (RTP) System
FDA Devices Moderate Aug 21, 2019
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
FDA Devices Moderate Aug 7, 2019
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
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 and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
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 delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
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 delivery
FDA Devices Moderate Aug 29, 2018
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
FDA Devices Moderate Aug 29, 2018
MOSAIQ Oncology Information System
FDA Devices Moderate Aug 1, 2018
HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy
FDA Devices Moderate Dec 20, 2017
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
FDA Devices Moderate Sep 13, 2017
MOSAIQ Medical Charged-Particle Radiation Therapy System
FDA Devices Moderate Aug 16, 2017
iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
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 few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arte
FDA Devices Moderate Jul 5, 2017
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: 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. Users can configure MOSAIQ¿ for Medical Oncology use, Radiation Oncology use, or the two together. It lets users: Assemble electronic patient charts and treatment plans,
Elekta, Inc. carries an outsized archive share
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (116 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Elekta, Inc.? ▼
PlainRecalls indexes 116 distinct federal recall events naming Elekta, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Elekta, Inc. sit among other recalling firms? ▼
Elekta, Inc. ranks #138 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Elekta, Inc.'s notices? ▼
FDA Devices accounts for 116 of this firm's 116 indexed notices.
What product category dominates Elekta, Inc.'s filing book? ▼
Filings for Elekta, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Elekta, Inc.: 116 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Elekta, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026