Elekta Recalls
122 recalls on record · July 18, 2012 to July 15, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 25, 2014Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports informa
Hazard: When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.
June 25, 2014Medical DevicesFDA
Elekta, Inc. recalls Synergy XVI Intended for radiation therapy treatment.
Hazard: XVI can incorrectly calculate the target position of the treatment table.
May 7, 2014Medical DevicesFDA
Elekta, Inc. recalls HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
Hazard: If screws are not properly tightened with a torque wrench they may become loose over time.
April 9, 2014Medical DevicesFDA
Elekta, Inc. recalls Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear acceler
Hazard: The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
March 26, 2014Medical DevicesFDA
Elekta, Inc. recalls SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics d
Hazard: Customers are resetting the default values outside recommended factory settings.
March 19, 2014Medical DevicesFDA
Elekta, Inc. recalls XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam rad
Hazard: Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear acc
Hazard: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear acc
Hazard: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear a
Hazard: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiati
Hazard: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user
Hazard: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
March 12, 2014Medical DevicesFDA
Elekta, Inc. recalls All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product
Hazard: Customers are resetting the default values outside recommended factory settings.
March 5, 2014Medical DevicesFDA
Elekta, Inc. recalls DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose deli
Hazard: It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
February 26, 2014Medical DevicesFDA
Elekta, Inc. recalls Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic disea
Hazard: Potential collision risk when using XVI and external beam shaping devices.
February 26, 2014Medical DevicesFDA
Elekta, Inc. recalls Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does n
Hazard: XVI can incorrectly calculate the target position of the treatment table.
February 12, 2014Medical DevicesFDA
Elekta, Inc. recalls XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or bra
Hazard: When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
January 29, 2014Medical DevicesFDA
Elekta, Inc. recalls XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam rad
Hazard: When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
November 13, 2013Medical DevicesFDA
Elekta, Inc. recalls Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medica
Hazard: Potential for clinical errors.
October 2, 2013Medical DevicesFDA
Elekta, Inc. recalls Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Hazard: Patient needs to be positioned as indicated by the treatment plan.
October 2, 2013Medical DevicesFDA
Elekta, Inc. recalls Monaco RTP System Radiation treatment planning
Hazard: Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
September 11, 2013Medical DevicesFDA
Elekta, Inc. recalls DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Hazard: Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
June 5, 2013Medical DevicesFDA
Elekta, Inc. recalls Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is re
Hazard: Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
April 17, 2013Medical DevicesFDA
Elekta, Inc. recalls Precise Treatment Table. To be used as part of radiation therapy treatment process.
Hazard: The Column rotation can accidentally be moved to a different position which in the locked position.
March 20, 2013Medical DevicesFDA
Elekta, Inc. recalls Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radia
Hazard: The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
March 6, 2013Medical DevicesFDA
Elekta, Inc. recalls Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Hazard: If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
February 27, 2013Medical DevicesFDA
Elekta, Inc. recalls Monaco RTP System. Radiation treatment planning.
Hazard: The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
November 7, 2012Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It le
Hazard: A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
October 31, 2012Medical DevicesFDA
Elekta, Inc. recalls Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments i
Hazard: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
September 26, 2012Medical DevicesFDA
Elekta, Inc. recalls Precise Digital Accelerator Delivery of radiation to defined target volumes
Hazard: There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
September 19, 2012Medical DevicesFDA
Elekta, Inc. recalls Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiati
Hazard: Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.