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 |
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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