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.

1–25 of 116

  • SevereFDA (Devices)·Z-2712-2026·2026-07-15

    Elekta Geneva Brachytherapy Applicator Intrauterine Tube Detachment Risk

    Elekta is recalling the Geneva Brachytherapy Applicator due to a safety concern that the tip of the intrauterine tube may detach and remain inside a patient during cancer treatment.

    Product
    Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2711-2026·2026-07-15

    Brachytherapy Applicator Advanced Gynecological Applicator Tip Detachment

    Elekta, Inc. is recalling Advanced Gynecological Applicators due to potential detachment of the intrauterine tube tip, which may remain inside a patient during cancer treatment.

    Product
    Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2710-2026·2026-07-15

    Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled

    Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.

    Product
    Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2026·2026-06-17

    MOSAIQ oncology software may fail to load adapted treatment plan

    The MOSAIQ Oncology Information System is being recalled because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2026·2026-05-06

    Leksell Vantage Arc System locking mechanism may not secure properly

    Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.

    Product
    Brand Name: Leksell Vantage Arc System REF: 1053958
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-1581-2026·2026-03-25

    Leksell Gamma Knife recalled over adapter not properly aligned or locked

    Elekta is recalling Leksell Gamma Knife radiosurgery systems, covering the Perfexion, Icon and Elekta Esprit models, due to an adapter not being properly aligned or locked in place.

    Product
    Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2026·2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2026·2026-02-18

    GammaPlan software recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan versions 11.3 and 11.4 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2026·2026-02-04

    Linear accelerators recalled over a manufacturing and electrical grounding issue

    Elekta is recalling 5,391 medical linear accelerators, covering Elekta Synergy, Harmony, Infinity and Versa HD, due to a manufacturing issue and electrical grounding of systems.

    Product
    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1078-2026·2026-01-21

    Oncology information system recalled over a potential for overtreatment

    Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.

    Product
    MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2026·2025-11-12

    Stereotactic frames recalled because paint flakes may enter the wound

    Elekta is recalling 338 Leksell Vantage Stereotactic System components because paint flakes from the engravings may separate and could inadvertently enter the wound.

    Product
    Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2024·2023-12-13

    Medical Radiation Therapy System Detector Arm Malfunction Poses Uncontrolled Extension Risk

    Elekta recalled its ELEKTA AXESSE radiation therapy system due to potential uncontrolled extension of detector arms if the microswitch is incorrectly configured. The recall affects 47 units distributed worldwide.

    Product
    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0443-2024·2023-12-13

    Medical Radiation Therapy System Potential Detector Arm Malfunction Due to Microswitch Issue

    Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.

    Product
    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0444-2024·2023-12-13

    Radiation Therapy System Detector Arm Microswitch Defect May Cause Uncontrolled Extension

    Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.

    Product
    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0445-2024·2023-12-13

    Elekta Versa HD radiation therapy system detector arm uncontrolled extension risk

    Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.

    Product
    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0446-2024·2023-12-13

    Medical radiation therapy system detector arm extension recall

    Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.

    Product
    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0442-2024·2023-12-13

    Medical Radiation Therapy Device Microswitch May Cause Uncontrolled Detector Arm Extension

    Elekta radiation therapy accelerators may experience uncontrolled detector arm extension due to an incorrectly set microswitch in the middle arm. The issue affects 315 units worldwide.

    Product
    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1675-2023·2023-06-14

    Elekta Unity Image-Guided Radiation Therapy System Electrical Connector Overheating Risk

    Elekta, Inc. is recalling 18 Elekta Unity Image-Guided Radiation Therapy Systems due to a potential electrical connector overheat hazard in the MR gradient coil. No injuries have been reported.

    Product
    Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1665-2023·2023-06-07

    Elekta Medical Linear Accelerator Component Non-Compliant with Safety Standard

    Elekta Inc. is recalling a limited number of Elekta Linacs due to a component non-compliant with safety standards. No reported injuries or illnesses.

    Product
    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1233-2023·2023-03-15

    Monaco RTP System software may calculate radiation therapy doses inaccurately

    Elekta's Monaco RTP radiation therapy treatment planning software may display inaccurate radiation doses when re-optimizing plans after adding anatomical contours. The defect affects 2,020 units distributed nationwide and internationally.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2023·2022-12-21

    Oncentra Brachy Radiation Therapy Software Reconstruction Error

    Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.

    Product
    Oncentra Brachy radiation therapy planning system software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2022·2021-11-03

    Brachytherapy Planning Software Dose Calculation Discrepancy

    Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.

    Product
    Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0116-2022·2021-10-20

    Elekta Medical Linear Accelerator Diode Component Destructive Failure Risk

    Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.

    Product
    Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2021·2021-10-06

    MOSAIQ Oncology Information System software defect reverts approved drug strength

    The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    17 states

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.