Elekta, Inc.: FDA recalls

FDA enforcement reports name Elekta, Inc. as the recalling firm in 105 events. The events have 116 product records. The recalls started from 2012 to 2026. All the events are device recalls.

See the 105 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

105 events, newest first.

FDA enforcement events of Elekta, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
21 May 2026	MOSAIQ Oncology Information System	Device	Class II	1	Ongoing
3 Apr 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.	Device	Class II	3	Ongoing
19 Mar 2026	Brand Name: Leksell Vantage Arc System REF: 1053958	Device	Class II	1	Ongoing
18 Feb 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…	Device	Class II	1	Ongoing
14 Dec 2025	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	Device	Class II	1	Ongoing
12 Dec 2025	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.	Device	Class II	2	Ongoing
10 Dec 2025	MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)	Device	Class II	1	Ongoing
30 Sep 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…	Device	Class II	1	Ongoing
15 Jan 2025	MOSAIQ Oncology Information System	Device	Class II	1	Ongoing
25 Oct 2023	ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear	Device	Class II	6	Ongoing
5 May 2023	Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy	Device	Class II	1	Ongoing
6 Apr 2023	Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.	Device	Class II	1	Ongoing
28 Feb 2023	Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Ongoing
5 Dec 2022	Oncentra Brachy radiation therapy planning system software.	Device	Class II	1	Ongoing
13 Oct 2021	Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00	Device	Class II	1	Ongoing
17 Sep 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	Device	Class II	1	Terminated
14 Sep 2021	Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Ongoing
2 Sep 2021	MOSAIQ Oncology Information System	Device	Class II	1	Ongoing
26 Jul 2021	Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10	Device	Class II	1	Ongoing
20 Apr 2021	Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud	Device	Class II	1	Terminated
30 Apr 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.	Device	Class II	1	Terminated
16 Apr 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	Device	Class II	1	Ongoing
30 Mar 2020	Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument	Device	Class II	1	Terminated
18 Dec 2019	Elekta Unity, Image-Guided Radiation Therapy System	Device	Class II	1	Terminated
22 Nov 2019	Monaco Radiation Treatment Planning System (RTP) System	Device	Class II	1	Ongoing
4 Sep 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,…	Device	Class II	2	Ongoing
23 Aug 2019	Monaco Radiation Treatment Planning System (RTP) System	Device	Class II	1	Terminated
3 Jul 2019	Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System	Device	Class II	1	Ongoing
24 Jun 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…	Device	Class II	1	Terminated
19 Jun 2019	iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2	Device	Class II	1	Terminated
8 Feb 2019	Monaco Radiation Treatment Planning (RTP) System	Device	Class II	1	Terminated
13 Dec 2018	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.	Device	Class II	1	Ongoing
4 Dec 2018	MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery	Device	Class II	1	Terminated
3 Aug 2018	MOSAIQ Oncology Information System	Device	Class II	1	Terminated
16 May 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	Device	Class II	1	Terminated
1 Dec 2017	ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD	Device	Class II	1	Terminated
1 Sep 2017	Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.	Device	Class II	1	Terminated
30 Jun 2017	MOSAIQ Medical Charged-Particle Radiation Therapy System	Device	Class II	1	Terminated
21 Jun 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…	Device	Class II	1	Terminated
19 Jun 2017	iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.	Device	Class II	1	Terminated
23 May 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,…	Device	Class II	1	Terminated
10 Jan 2017	Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
23 Dec 2016	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.	Device	Class II	1	Terminated
21 Dec 2016	Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
2 Dec 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.	Device	Class II	1	Terminated
17 Nov 2016	Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
3 Nov 2016	Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
29 Sep 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…	Device	Class II	1	Terminated
18 Aug 2016	Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
18 Aug 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.	Device	Class II	1	Terminated
15 Jul 2016	MOSAIQ Oncology Information System	Device	Class II	1	Ongoing
8 Jul 2016	Medical Linear Accelerator	Device	Class II	1	Terminated
17 Jun 2016	MOSAIQ Oncology Information System	Device	Class II	1	Terminated
18 May 2016	Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
12 May 2016	iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.	Device	Class II	1	Terminated
19 Apr 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.	Device	Class II	1	Terminated
18 Dec 2015	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.	Device	Class II	1	Terminated
9 Dec 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.	Device	Class II	1	Terminated
24 Nov 2015	MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.	Device	Class II	1	Terminated
16 Oct 2015	Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
15 Sep 2015	Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.	Device	Class II	1	Terminated
31 Aug 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.	Device	Class II	1	Terminated
1 Jul 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.	Device	Class II	1	Terminated
1 Jun 2015	Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.	Device	Class II	1	Terminated
21 May 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.	Device	Class II	1	Terminated
29 Jan 2015	Elekta Precise Treatment Table	Device	Class II	1	Terminated
7 Jan 2015	Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.	Device	Class II	1	Terminated
19 Dec 2014	Focal Sim radiation therapy treatment planning system	Device	Class II	1	Terminated
19 Dec 2014	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…	Device	Class II	1	Terminated
3 Nov 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.	Device	Class II	1	Terminated
6 Oct 2014	Laksell Gamma Knife Perfexion	Device	Class II	1	Terminated
18 Aug 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.	Device	Class II	1	Terminated
18 Aug 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…	Device	Class II	1	Terminated
29 May 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.	Device	Class II	1	Terminated
29 May 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.	Device	Class II	1	Terminated
23 May 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.	Device	Class II	1	Terminated
23 Apr 2014	Synergy XVI Intended for radiation therapy treatment.	Device	Class II	1	Terminated
17 Apr 2014	HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.	Device	Class II	1	Terminated
17 Feb 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…	Device	Class II	1	Terminated
25 Nov 2013	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…	Device	Class II	1	Terminated
25 Nov 2013	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.	Device	Class II	1	Terminated
25 Nov 2013	XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.	Device	Class II	1	Terminated
25 Nov 2013	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.	Device	Class II	1	Terminated
25 Nov 2013	XiO RTP 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…	Device	Class II	1	Terminated
25 Nov 2013	Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.	Device	Class II	3	Terminated
25 Nov 2013	Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.	Device	Class II	1	Terminated
15 Aug 2013	DMLC IV-ERGO - Beam shaping block for Radiation Therapy.	Device	Class II	1	Terminated
23 Jul 2013	Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.	Device	Class II	1	Terminated
2 Jul 2013	Monaco RTP System Radiation treatment planning	Device	Class II	1	Terminated
28 May 2013	All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes	Device	Class II	1	Terminated
28 May 2013	SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.	Device	Class II	1	Terminated
22 May 2013	Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.	Device	Class II	1	Terminated
1 May 2013	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.	Device	Class II	1	Terminated
30 Apr 2013	Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.	Device	Class II	1	Terminated
28 Mar 2013	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.	Device	Class II	1	Terminated
14 Mar 2013	Precise Treatment Table. To be used as part of radiation therapy treatment process.	Device	Class II	1	Terminated
11 Feb 2013	Monaco RTP System. Radiation treatment planning.	Device	Class II	1	Terminated
18 Jan 2013	Elekta, Apex add-on Micro MLC, collimator for radiation therapy.	Device	Class II	1	Terminated
19 Dec 2012	Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.	Device	Class II	1	Terminated
18 Sep 2012	MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive…	Device	Class II	1	Terminated
21 Aug 2012	Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.	Device	Class II	1	Terminated
6 Aug 2012	Precise Digital Accelerator Delivery of radiation to defined target volumes	Device	Class II	1	Terminated
27 Jul 2012	Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.	Device	Class II	1	Terminated
21 Jun 2012	Monaco Product Usage: Planning of radiation therapy	Device	Class II	1	Terminated
21 Jun 2012	Focal SIM Planning of radiation therapy	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Elekta, Inc.: events for each product type
Type		Events
Device		105

Elekta, Inc.: events in each class
Class		Events
Class II		105

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 24

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Elekta, Inc., by the year that the recall started. The largest year is 2013, with 19 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Elekta, Inc.: FDA recalls. https://recallregister.com/firm/elekta-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: GA, MO

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Elekta, Inc. have?: Class II: 105 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Elekta, Inc.?: FDA event 98980, which the firm started on 21 May 2026. The first product in the record is: MOSAIQ Oncology Information System
How many FDA recalls of Elekta, Inc. have the status Ongoing?: 24 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.