Elekta recalls
18 official recalls and safety alerts involving Elekta since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Elekta or the relevant agency.
- 2026-07-15
USElekta, Inc. recalls Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The…
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AR, AZ,…Official notice →- 2026-06-17
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA · DeviceElekta, Inc.Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY,…Official notice → - 2026-05-06
- US
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
FDA · DeviceElekta, Inc.US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA…Official notice → - 2026-03-25
- US
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
Due to adapter not being properly aligned or locked in place.
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice → - 2026-02-18
- US
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description:…
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…
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice → - 2026-02-04
- US
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version:…
Due to a manufacturing issue and electrical grounding of systems.
- 2026-01-21
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
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…
- 2025-11-12
- US
Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The…
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
FDA · DeviceElekta, Inc.Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID,…Official notice → - 2025-02-19
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
FDA · DeviceElekta, Inc.US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina…Official notice → - 2023-12-13
- US
Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator,…
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…
- 2023-06-14
- US
Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
FDA · DeviceElekta, Inc.US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI,…Official notice → - 2023-06-07
- US
Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
FDA · DeviceElekta, Inc.Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA.…Official notice → - 2023-03-15
- US
Elekta Inc recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
FDA · DeviceElekta IncNationwide distribution in the US. International distribution to Albania,…Official notice → - 2022-12-21
- US
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
FDA · DeviceElekta, Inc.Distribution US nationwide, including Puerto Rico. There was no…Official notice → - 2021-11-03
- US
Elekta, Inc. recalls Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
FDA · DeviceElekta, Inc.Distribution throughout USA OUS distribution including:Algeria, Argentina,…Official notice → - 2021-10-20
- US
Elekta, Inc. recalls Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta…
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.
FDA · DeviceElekta, Inc.Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA,…Official notice → - 2021-10-06
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA · DeviceElekta, Inc.Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH,…Official notice → - US
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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.
FDA · DeviceElekta IncWorldwide distribution - US Nationwide distribution in the states of PA, MI,…Official notice →