Elekta, Inc.
78 recalls on record · Latest: Jan 21, 2026
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