PlainRecalls

Elekta, Inc.

Compiled from official public sources by the editorial team.

112 recalls on record · Latest: May 6, 2026

Elekta, Inc. Recall Insight

Elekta, Inc. appears on 112 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.110% 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 May 6, 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 Oct 2, 2013 to Dec 7, 2016.

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 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 8, 2016

Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation th…

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 13, 2016

Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software d…

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 Oct 14, 2015

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

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 Jun 17, 2015

Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.

FDA Devices Moderate Jun 10, 2015

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating…

FDA Devices Moderate Mar 25, 2015

Elekta Precise Treatment Table

FDA Devices Moderate Mar 11, 2015

Focal Sim radiation therapy treatment planning system

FDA Devices Moderate Mar 11, 2015

Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for exter…

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…

FDA Devices Moderate Nov 5, 2014

Laksell Gamma Knife Perfexion

FDA Devices Moderate Sep 10, 2014

FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also able to perf…

FDA Devices Moderate Sep 10, 2014

Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculat…

FDA Devices Moderate Jul 2, 2014

MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among h…

FDA Devices Moderate Jun 25, 2014

MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare fa…

FDA Devices Moderate Jun 25, 2014

Synergy XVI Intended for radiation therapy treatment.

FDA Devices Moderate Jun 25, 2014

iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking S…

FDA Devices Moderate May 7, 2014

HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.

FDA Devices Moderate Apr 9, 2014

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assi…

FDA Devices Moderate Mar 26, 2014

SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

FDA Devices Moderate Mar 19, 2014

XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachythera…

FDA Devices Moderate Mar 12, 2014

Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated…

FDA Devices Moderate Mar 12, 2014

Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Devices Moderate Mar 12, 2014

Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.

FDA Devices Moderate Mar 12, 2014

RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Ser…

FDA Devices Moderate Mar 12, 2014

Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated…

FDA Devices Moderate Mar 12, 2014

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation t…

FDA Devices Moderate Mar 5, 2014

DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes o…

FDA Devices Moderate Feb 26, 2014

Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licen…

FDA Devices Moderate Feb 26, 2014

Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. Thi…

FDA Devices Moderate Feb 12, 2014

XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribe…

FDA Devices Moderate Jan 29, 2014

XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachythera…

FDA Devices Moderate Nov 13, 2013

Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in ra…

FDA Devices Moderate Oct 2, 2013

Monaco RTP System Radiation treatment planning

FDA Devices Moderate Oct 2, 2013

Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Elekta, Inc. with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.