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.

101–116 of 116

  • SevereFDA (Devices)·Z-0780-2014·2014-01-29

    Elekta XiO RTP System Recalled for Dose Calculation Error

    Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.

    Product
    XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional rad
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0138-2014·2013-11-13

    Elekta Recalls Stereotactic Circular Collimators Due to Potential Clinical Errors

    Elekta, Inc. is recalling 89 Stereotactic Circular Collimators used in radiotherapy for head tumors due to a potential for clinical errors.

    Product
    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2013·2013-10-02

    Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System

    Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.

    Product
    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2276-2013·2013-10-02

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.

    Product
    Monaco RTP System Radiation treatment planning
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2157-2013·2013-09-11

    Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy

    Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.

    Product
    DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2013·2013-06-05

    Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues

    Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.

    Product
    Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2013·2013-04-17

    Elekta Precise Treatment Table Recalled for Column Rotation Defect

    Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.

    Product
    Precise Treatment Table. To be used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2013·2013-03-20

    Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect

    Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.

    Product
    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2013·2013-03-06

    Elekta Apex add-on Micro MLC collimator recall for installation defect

    Elekta, Inc. is recalling Apex add-on Micro MLC collimators for radiation therapy because incorrect installation may cause the touchguard inhibit to activate and restrict the view restrictions dialog box.

    Product
    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0841-2013·2013-02-27

    Elekta Monaco RTP System Recalled for Beam Angle Calculation Error

    Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.

    Product
    Monaco RTP System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0169-2013·2012-11-07

    Elekta MOSAIQ Medical Record System Recalled for Treatment Data Error

    Elekta, Inc. is recalling MOSAIQ electronic medical record systems because a user error led to a patient being seriously mistreated.

    Product
    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2013·2012-10-31

    Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software

    Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.

    Product
    Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2012·2012-09-26

    Elekta Precise Digital Accelerator Recall Due to Loose Drive Gear Joint

    Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Precise Digital Accelerator Delivery of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2012·2012-09-19

    Elekta Agility Multileaf Collimator Recall for Missing Compatibility Information

    Elekta is recalling two Agility Multileaf Collimators because the original product information did not specify compatibility with the Dynamic Multileaf Collimator Apex add-on.

    Product
    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    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.