PlainRecalls

Elekta, Inc.

Compiled from official public sources by the editorial team.

112 recalls on record · Latest: May 6, 2026

Elekta, Inc. Recall Insight

Elekta, Inc. appears on 112 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.110% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated May 6, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Dec 21, 2016 to May 6, 2026.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 Espri…

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 Ga…

FDA Devices Moderate Feb 18, 2026

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPla…

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 Produc…

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 …

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 Syn…

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 stereotact…

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…

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 w…

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 …

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 an…

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 del…

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 de…

FDA Devices Moderate Aug 29, 2018

ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axess…

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 pos…

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 f…

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 workfl…

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 trea…

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 amon…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.