The Recall Desk

Manufacturer

Elekta, Inc.

116 recalls in our database name Elekta, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
116
Critical
0
Severe
17
Most recent
2026-07-15

Of the 116 recalls from Elekta, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 17 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 116

  • HighFDA (Devices)·Z-2563-2021·2021-10-06

    Radiation therapy planning software can save contours to wrong image set

    Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.

    Product
    Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2021·2021-09-08

    Monaco RTP System software defect may cause incorrect radiation therapy dose calculations

    Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.

    Product
    Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1783-2021·2021-06-09

    Elekta MOSAIC Oncology Information System Recalled Due to Malware Attack

    Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.

    Product
    Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2473-2020·2020-07-08

    Elekta Unity Radiation Therapy System Recalled for Heating Issues

    Elekta, Inc. is recalling 21 Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2289-2020·2020-06-17

    Elekta Unity Radiation Therapy System Recalled for Legionella Risk

    Elekta, Inc. is recalling 32 Unity image-guided radiation therapy systems due to a potential risk of Legionella presence in the machine room heat exchanger condensation collection tray.

    Product
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1825-2020·2020-05-06

    Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery

    Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2020·2020-05-06

    Elekta Recalls Leksell Vantage Stereotactic System Instrument Carriers

    Elekta Inc is recalling 25 Leksell Vantage Stereotactic System Instrument Carriers because a faulty locking piece may not meet required locking force standards.

    Product
    Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2020·2019-12-18

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2561-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 49 Monaco RTP Systems because unintentional changes to electron density settings may cause incorrect dose calculations for radiation therapy plans.

    Product
    Monaco RTP System, 5.50/5.51, 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2560-2019·2019-10-02

    Elekta Monaco RTP System Recalled for Potential Dose Calculation Errors

    Elekta Inc is recalling 30 units of the Monaco RTP System 5.40 Unity because unintentional changes to electron density settings may result in incorrect dose calculations for radiation treatment plans.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2230-2019·2019-08-21

    Elekta iGUIDE System Recalled for Potential Position Monitoring Error

    Elekta is recalling 374 iGUIDE Systems because they may incorrectly monitor 3D position. The recall covers devices distributed nationwide and worldwide.

    Product
    iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2091-2019·2019-08-07

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco RTP System software versions 5.10 and 5.11 due to a defect that causes incorrect Monitor Unit scaling when specific plan parameters are changed.

    Product
    Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    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 pract
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0965-2019·2019-03-06

    Elekta Recalls Monaco Radiation Treatment Planning System Software

    Elekta, Inc. is recalling 14 Monaco Radiation Treatment Planning System devices due to a software defect that may cause incorrect optimization models to be used during online plan adaptation.

    Product
    Monaco Radiation Treatment Planning (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0821-2019·2019-02-20

    Elekta MOSAIQ Oncology System Recalled for Potential Radiation Dose Errors

    Elekta is recalling MOSAIQ Oncology Information Systems because missing wedge IDs may cause patients to receive higher radiation doses than planned.

    Product
    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2019·2019-01-02

    Elekta Recalls MOSAIQ Oncology Software Due to Isocenter Copying Error

    Elekta is recalling MOSAIQ Oncology Information System Version 2.64 because copied treatment fields may retain incorrect isocenter settings for imaging.

    Product
    MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2840-2018·2018-08-29

    Elekta Digital Accelerator Recall for Potential Uncontrolled Detector Arm Extension

    Elekta is recalling 2,998 Digital Accelerators worldwide due to a potential for uncontrolled extension of iViewGT or XVI detector arms.

    Product
    ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2018·2018-08-01

    Elekta Recalls HexaPOD evo RT Couch Top for Positioning Errors

    Elekta, Inc. is recalling 725 HexaPOD evo RT Couch Top devices because they may tilt incorrectly after specific workflows, leading to improper patient positioning during radiation therapy.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2018·2017-12-20

    Elekta ERGO++ Medical Device Recall for Incorrect DICOM Mapping

    Elekta Inc is recalling 182 ERGO++ devices due to incorrect DICOM mapping of collimator or couch angles, which may lead to incorrect rotation during planning.

    Product
    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3110-2017·2017-09-13

    Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error

    Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.

    Product
    MOSAIQ Medical Charged-Particle Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2697-2017·2017-07-19

    Elekta Leksell Gamma Knife Icon Recall for Electrical Safety Risk

    Elekta is recalling two Leksell Gamma Knife Icon units due to a potential electrical safety risk for technicians performing maintenance.

    Product
    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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2633-2017·2017-07-05

    Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure

    Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Elekta

company

Country
Sweden
Founded
1972

Official website

Source: Wikidata (Q830608), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.