PlainRecalls

Elekta, Inc.

79 recalls on record · Latest: Feb 18, 2026

Elekta, Inc. Recall Insight

Elekta, Inc. appears on 79 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.094% 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 Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 29 entries, severity tagging shows 0 critical, 29 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 29 of 29 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 (29). The date window on this page runs from Jul 18, 2012 to Nov 5, 2014.

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 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 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 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.

FDA Devices Moderate Jun 5, 2013

Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radi…

FDA Devices Moderate Mar 20, 2013

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 proces…

FDA Devices Moderate Mar 6, 2013

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

FDA Devices Moderate Feb 27, 2013

Monaco RTP System. Radiation treatment planning.

FDA Devices Moderate Nov 7, 2012

MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic pa…

FDA Devices Moderate Oct 31, 2012

Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the pur…

FDA Devices Moderate Sep 19, 2012

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 …

FDA Devices Moderate Jul 18, 2012

Focal SIM Planning of radiation therapy

FDA Devices Moderate Jul 18, 2012

Monaco Product Usage: Planning of radiation therapy

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Data Sources

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