PlainRecalls

Elekta, Inc.

79 recalls on record · Latest: Feb 18, 2026

Elekta, Inc. Recall Insight

Elekta, Inc. appears on 79 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.094% 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 Feb 18, 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 Nov 26, 2014 to Feb 18, 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 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 Jan 21, 2026

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

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 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 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 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 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 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 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…

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 …

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 Tracki…

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 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…

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 suppo…

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 brachythe…

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 support…

FDA Devices Moderate Mar 25, 2015

Elekta Precise Treatment Table

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 med…

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 informati…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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