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.

51–75 of 116

  • SevereFDA (Devices)·Z-1044-2017·2017-01-25

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors

    Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.

    Product
    Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-1009-2017·2017-01-18

    Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations

    Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.

    Product
    Monaco RTP System 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-0987-2017·2017-01-18

    Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect

    Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.

    Product
    Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2017·2016-12-21

    Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error

    Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.

    Product
    MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0660-2017·2016-12-07

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.

    Product
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0668-2017·2016-12-07

    Elekta Monaco TRP System Software Recall for CT Data Handling Error

    Elekta, Inc. is recalling the Monaco TRP System software because it may incorrectly handle CT datasets with specific DICOM Z coordinates, potentially affecting treatment plan accuracy.

    Product
    Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-0076-2017·2016-10-19

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 365 Monaco RTP Systems because a software error can cause incorrect MU scaling when specific plan parameters are modified.

    Product
    Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distri
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2721-2016·2016-09-14

    Elekta Medical Linear Accelerator Recall for Loose Drive Gear Joint

    Elekta is recalling 553 Medical Linear Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Medical Linear Accelerator
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2691-2016·2016-09-07

    Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

    Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

    Product
    HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2016·2016-09-07

    Elekta Monaco RTP System Software Recall for Contour Deletion Error

    Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.

    Product
    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2293-2016·2016-08-03

    Elekta Recalls MOSAIQ Oncology System Due to Potential Dosing Errors

    Elekta is recalling 383 units of the MOSAIQ Oncology Information System because a software issue may prevent order changes from saving, potentially resulting in incorrect chemotherapy doses.

    Product
    MOSAIQ Oncology Information System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2016·2016-06-08

    Elekta Monaco RTP System Recalled for Treatment Planning Error

    Elekta is recalling Monaco RTP System software versions 5.10.00 and higher because a specific export setting causes incorrect jaw positioning in radiation therapy plans.

    Product
    Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1561-2016·2016-05-04

    Elekta Radionuclide Radiation Therapy System Recalled for Frame Adapter Latch Defect

    Elekta is recalling 217 Radionuclide Radiation Therapy Systems because frame adapter latches can lock without proper pin insertion, potentially compromising treatment accuracy.

    Product
    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2016·2016-01-13

    Elekta Oncentra VMAT Radiation Therapy Planning System Recalled for Software Error

    Elekta, Inc. is recalling 154 units of the Oncentra External Beam - VMAT radiation therapy planning system because a software error may cause the system to incorrectly include organs at risk as target volumes.

    Product
    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0557-2016·2016-01-06

    Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error

    Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.

    Product
    MOSAIQ Oncology Information System 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 are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2016·2015-12-23

    Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure

    Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.

    Product
    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2016·2015-11-04

    Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

    Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

    Product
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0130-2016·2015-10-28

    Elekta XiO Radiation Treatment Planning System Recalled for Incorrect Treatment Delivery

    Elekta is recalling 1,440 XiO Radiation Treatment Planning Systems because they may deliver incorrect treatments when using third-party fixed wedges.

    Product
    XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-0112-2016·2015-10-14

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco Radiation Treatment Planning System software version 5.10.00 because it may calculate incorrect dose and MU values under specific conditions.

    Product
    Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2063-2015·2015-07-22

    Elekta MOSAIQ Oncology Software Recalled for Incorrect Stereotactic Field Size

    Elekta is recalling MOSAIQ Oncology Information System software due to a defect that sends incorrect field sizes to treatment machines for stereotactic plans using cones.

    Product
    MOSAIQ Oncology Information System 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 are prescribed.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1719-2015·2015-06-17

    Elekta Recalls Leksell GammaPlan Software Due to Memory Corruption

    Elekta is recalling 10 units of Leksell GammaPlan 10.2 software because memory can become corrupted when creating a fused study via drag and drop.

    Product
    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2015·2015-06-10

    Elekta Oncentra Brachy software recalled for incorrect dose calculation errors

    Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning software because it may calculate incorrect doses for specific regions of interest.

    Product
    Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1238-2015·2015-03-25

    Elekta Precise Treatment Table Recalled for Positioning Error Risk

    Elekta is recalling Precise Treatment Tables because incorrect sensor installation during maintenance can cause undetected positioning errors, potentially leading to clinical mistreatment.

    Product
    Elekta Precise Treatment Table
    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.