Brand

Elekta, Inc. Recalls

78 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Elekta, Inc..

78Total Recalls
0Critical
39,015Units Affected
Mar 19, 2026Most Recent
All Recalls

Every Elekta, Inc. Recall

Sorted by most recent. Click any recall for full details.

78 recalls
High RiskFDA
Elekta, Inc.
Elekta Precise Treatment Table
Medical Devices·529 affected·Jan 29, 2015
High RiskFDA
Elekta, Inc.
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a ...
Medical Devices·46 affected·Jan 7, 2015
High RiskFDA
Elekta, Inc.
MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It suppor...
Medical Devices·15 affected·Nov 3, 2014
High RiskFDA
Elekta, Inc.
Laksell Gamma Knife Perfexion
Medical Devices·181 affected·Oct 6, 2014
High RiskFDA
Elekta, Inc.
FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patient contouring and viewing of treatment plan outputs. Also ...
Medical Devices·554 affected·Aug 18, 2014
High RiskFDA
Elekta, Inc.
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 3...
Medical Devices·224 affected·May 29, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among h...
Medical Devices·723 affected·May 23, 2014
High RiskFDA
Elekta, Inc.
Synergy XVI Intended for radiation therapy treatment.
Medical Devices·380 affected·Apr 23, 2014
High RiskFDA
Elekta, Inc.
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·300 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or...
Medical Devices·13 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined tar...
Medical Devices·1,309 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Medical Devices·455 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has be...
Medical Devices·1,424 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
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 th...
Medical Devices·489 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determine...
Medical Devices·312 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which i...
Medical Devices·134 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very fre...
Medical Devices·1,028 affected·Nov 25, 2013
High RiskFDA
Elekta, Inc.
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that ar...
Medical Devices·89 affected·Jul 23, 2013
High RiskFDA
Elekta, Inc.
Monaco RTP System Radiation treatment planning
Medical Devices·45 affected·Jul 2, 2013
High RiskFDA
Elekta, Inc.
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of...
Medical Devices·472 affected·May 28, 2013
High RiskFDA
Elekta, Inc.
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometric...
Medical Devices·35 affected·May 1, 2013
High RiskFDA
Elekta, Inc.
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conform...
Medical Devices·31 affected·Apr 30, 2013
High RiskFDA
Elekta, Inc.
Monaco RTP System. Radiation treatment planning.
Medical Devices·13 affected·Feb 11, 2013
High RiskFDA
Elekta, Inc.
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Medical Devices·1 affected·Jan 18, 2013
High RiskFDA
Elekta, Inc.
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 trea...
Medical Devices·164 affected·Dec 19, 2012
High RiskFDA
Elekta, Inc.
MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply e...
Diagnostic Devices·300 affected·Sep 18, 2012
High RiskFDA
Elekta, Inc.
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension...
Medical Devices·52 affected·Aug 21, 2012
High RiskFDA
Elekta, Inc.
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas ...
Medical Devices·2 affected·Jul 27, 2012
High RiskFDA
Elekta, Inc.
Focal SIM Planning of radiation therapy
Medical Devices·38 affected·Jun 21, 2012
High RiskFDA
Elekta, Inc.
Monaco Product Usage: Planning of radiation therapy
Medical Devices·38 affected·Jun 21, 2012