Elekta, Inc.
116 recalls on record · Latest: Jul 15, 2026
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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
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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 Jan 25, 2017
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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 treatment is three dimensions for the purpose of treating patients with cancer.
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 among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
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 calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
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 Tracking System in a radiotherapy environment.
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 8, 2016
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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 from very small target sizes of a few millimeters to several centimeters.
FDA Devices Moderate Jan 13, 2016
Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
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 supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
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 brachytherapy has been prescribed.
FDA Devices Moderate Oct 14, 2015
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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 supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
FDA Devices Moderate Jun 17, 2015
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
FDA Devices Moderate Jun 10, 2015
Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
FDA Devices Moderate Mar 25, 2015
Elekta Precise Treatment Table
FDA Devices Moderate Mar 11, 2015
Focal Sim radiation therapy treatment planning system
FDA Devices Moderate Mar 11, 2015
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron 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.
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 medical practitioner.
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 information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
FDA Devices Moderate Nov 5, 2014
Laksell Gamma Knife Perfexion
FDA Devices Moderate Sep 10, 2014
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perform CT simulations and forward their information to the RTP System for dose calculation.
FDA Devices Moderate Sep 10, 2014
Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron 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.
FDA Devices Moderate Jul 2, 2014
MOSAIQ 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 where ever radiotherapy and/or chemotherapy are prescribed.
FDA Devices Moderate Jun 25, 2014
MOSAIQ, 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 Jun 25, 2014
Synergy XVI Intended for radiation therapy treatment.
FDA Devices Moderate Jun 25, 2014
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
FDA Devices Moderate May 7, 2014
HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
FDA Devices Moderate Apr 9, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Devices Moderate Mar 26, 2014
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Devices Moderate Mar 19, 2014
XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.
FDA Devices Moderate Mar 12, 2014
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
FDA Devices Moderate Mar 12, 2014
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Devices Moderate Mar 12, 2014
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
FDA Devices Moderate Mar 12, 2014
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Devices Moderate Mar 12, 2014
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
FDA Devices Moderate Mar 12, 2014
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Devices Moderate Mar 5, 2014
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
FDA Devices Moderate Feb 26, 2014
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Devices Moderate Feb 26, 2014
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actua
FDA Devices Moderate Feb 12, 2014
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
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