Elekta, Inc.

Complete recall history across all FDA and CPSC categories — 101 total recalls

Elekta, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (101)

FDA medical device enforcement actions by Elekta, Inc.. Showing most recent 50.

Date Product Reason Class
Feb 18, 2026 Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Pe... Due to adapter not being properly aligned or locked in place. Class II
Dec 14, 2025 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ... Due to a manufacturing issue and electrical grounding of systems. Class II
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to... Class II
Dec 12, 2025 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... Due to an error when defining a new stereotactic reference that users fail to... Class II
Dec 10, 2025 MOSAIQ Oncology Information System with Particle Therapy License (License Ki... Using oncology information system that manages workflow may result in overtre... Class II
Sep 30, 2025 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... Due to increased risk that paint flakes from the engravings may separate from... Class II
Jan 15, 2025 MOSAIQ Oncology Information System Image offsets calculated by oncology Information System software may be in... Class II
Oct 25, 2023 ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical C... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Partic... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
Oct 25, 2023 ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation T... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
Oct 25, 2023 ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiati... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
Oct 25, 2023 ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charg... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
Oct 25, 2023 ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; M... Elekta has identified that if the microswitch within the middle arm is incorr... Class II
May 5, 2023 Elekta Medical Linear Accelerator (ELMA) included in the below platforms: ... A component within a limited number of Elekta Linacs has been realized to be ... Class II
Apr 6, 2023 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient ... There is a low possibility that an electrical connector in the MR gradient co... Class II
Dec 5, 2022 Oncentra Brachy radiation therapy planning system software. A reconstruction error may occur when using the Catheter Bending functionalit... Class II
Oct 13, 2021 Oncentra Brachy users using version 4.0 and above with Applicator Modeling li... Under certain circumstances, there can be a difference between the planned an... Class II
Sep 17, 2021 Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta... There is a risk that the Diode D1 in the Modulator can fail in a destructive ... Class II
Sep 2, 2021 MOSAIQ Oncology Information System A drug strength in MOSAIQ can be changed during the ordering process and appr... Class II
Apr 20, 2021 Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, ... Malware attack Class II
Apr 30, 2020 Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Pro... potential risk that Legionella may be present in the Unity machine room, spec... Class II
Dec 18, 2019 Elekta Unity, Image-Guided Radiation Therapy System There have been reports of excessive heating in the MRL Gradient Connection M... Class II
Aug 23, 2019 Monaco Radiation Treatment Planning System (RTP) System Monaco is displaying the Anatomy and Beam shift direction incorrectly on the ... Class II
Jun 24, 2019 Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Mag... The QA software solution to perform the MR to MV alignment check, does not di... Class II
Jun 19, 2019 iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Potential for iGUIDE to incorrectly monitor the 3D position. Class II
Feb 8, 2019 Monaco Radiation Treatment Planning (RTP) System If Improve Target Dose was chosen as an optimization model in a previous tr... Class II
Dec 13, 2018 MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology in... There is a potential that Wedge IDs were not included in the DICOM RT PLAN se... Class II
Dec 4, 2018 MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology i... If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field... Class II
Aug 3, 2018 MOSAIQ Oncology Information System Order Status Remains Approved When Should Indicate Complete. Class II
May 16, 2018 HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of t... Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted s... Class II
Dec 1, 2017 ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, S... There is a potential for an uncontrolled extension of iViewGT / XVI detector ... Class II
Jun 30, 2017 MOSAIQ Medical Charged-Particle Radiation Therapy System The table shift in the vertical direction was inverted during the use of CMA ... Class II
Jun 21, 2017 MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product... Retention of Outdated Information in an Order Set. In the Care Plan Library,... Class II
Jun 19, 2017 iGUIDE Software 2.2 Product Usage: Control of accurate patient positioni... Incorrect PEC values. Class II
May 23, 2017 Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic ir... If the gantry module is replaced after original installation the configuratio... Class II
Jan 10, 2017 Monaco RTP System. Used to make treatment plans for patients with prescrip... Incorrect dose after editing beam number an wedge angle. Class II
Dec 23, 2016 Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiati... Cross profile for Varian 60 degree wedge shows "horns." Class II
Dec 21, 2016 Monaco RTP System Product Usage: Used to make treatment plans for patient... Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. Class II
Dec 2, 2016 MOSAIQ Oncology Information System The product is used to manage workflow... Edits to Particle field definition parameters may not be saved when the field... Class II
Nov 17, 2016 Monaco TRP System The Monaco system is used to make treatment plans for pati... Contours are not handled correctly if the CT dataset contains slices with DIC... Class II
Nov 3, 2016 Monaco RTP System; Used to make treatment plans for patients with prescriptio... Incorrect Dose when using the reset function. Class II
Sep 29, 2016 Monaco RTP System The Monaco system is used to make treatment plans for pati... When creating 3D plans using either MU or Dose weighting modes, if the user c... Class II
Aug 18, 2016 Monaco RTP System Used to make treatment plans for patients with prescript... In a specific workflow where contours are edited (enlarged, moved, copied, et... Class II
Aug 18, 2016 HexaPOD evo RT System Product Usage: The intended use of the device is th... Potentially unrecognized incorrect position of the treatment couch in 3D work... Class II
Jul 15, 2016 MOSAIQ Oncology Information System It is possible that a change to an Order Set will not be saved in the current... Class II
Jul 8, 2016 Medical Linear Accelerator There have been instances in hospitals where the joint between the drive gear... Class II
Jun 17, 2016 MOSAIQ Oncology Information System It is possible that that the selected Plan-of-the Day could be accidently cha... Class II
May 18, 2016 Monaco RTP System Product Usage: The Monaco system is used to make treatm... When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (C... Class II
May 12, 2016 iGUIDE System, for patient positioning, with assistance of a 30 Tracking Syst... If by mistake the initial pre-treatment imaging was performed BEFORE the Hexa... Class II
Apr 19, 2016 Radionuclide Radiation Therapy System Product The product is a teletherapy... The latches of the frame adapter can be locked even if the locating pins of t... Class II

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Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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