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.
July 15, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitar
Hazard: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
July 15, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended
Hazard: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
July 15, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product
Hazard: Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
June 17, 2026Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System
Hazard: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
May 6, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Hazard: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
March 25, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel
Hazard: Due to adapter not being properly aligned or locked in place.
February 18, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr
Hazard: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
February 18, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product
Hazard: Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
February 4, 2026Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Hazard: Due to a manufacturing issue and electrical grounding of systems.
January 21, 2026Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Hazard: Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
November 12, 2025Medical DevicesFDA
Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ
Hazard: Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
February 19, 2025Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System
Hazard: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
December 13, 2023Medical DevicesFDA
Elekta, Inc. recalls ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac
Hazard: Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
June 14, 2023Medical DevicesFDA
Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Hazard: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
June 7, 2023Medical DevicesFDA
Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El
Hazard: A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
March 15, 2023Medical DevicesFDA
Elekta Inc recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy
Hazard: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
December 21, 2022Medical DevicesFDA
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
Hazard: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
November 3, 2021Medical DevicesFDA
Elekta, Inc. recalls Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Hazard: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
October 20, 2021Medical DevicesFDA
Elekta, Inc. recalls Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekt
Hazard: There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
October 6, 2021Medical DevicesFDA
Elekta, Inc. recalls MOSAIQ Oncology Information System
Hazard: A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
October 6, 2021Medical DevicesFDA
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation
Hazard: Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
September 8, 2021Medical DevicesFDA
Elekta Inc recalls Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Hazard: If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
June 9, 2021Medical DevicesFDA
Elekta, Inc. recalls Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Hazard: Malware attack
July 8, 2020Medical DevicesFDA
Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System
Hazard: There have been reports of excessive heating in the MRL Gradient Connection Module.
June 17, 2020Medical DevicesFDA
Elekta Limited recalls Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Hazard: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.