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Elekta Oy

Inactive in EUDAMED since 2024

Finlandfrom SRN EUDAMED FDA SRN FI-MF-000012331

Elekta Oy is a medical device manufacturer based in Finland, with 1 device listed in EUDAMED (EU Class IIa) and 162 FDA recalls as of 14 Nov 2026.

Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.

Devices
1
Registrations
EUDAMEDFDA
FDA recalls
16226 ongoing since 2021 (33 open in total)
7 open since before 2021

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 1
Device classes
  • EU Class IIa 1
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN FI-MF-000012331

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

What Elekta Oy makes

Elekta Oy manufactures ultrasound imaging systems under the Kaiku Health brand, including diagnostic and therapeutic devices designed for medical imaging and treatment guidance. These products are primarily used in radiology and interventional procedures to enhance visualization of soft tissues and organs.

The company’s portfolio is regulated as Class IIa medical devices in the European Union and is listed in the EUDAMED registry. Elekta Oy operates from Finland and adheres to EU medical device regulations.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Kaiku Health Ref Kaiku Health major version 7

    Withdrawn Regimes: CE MDD, withdrawn Registry: EUDAMED Class:IIa

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FI-MF-000012331
EU VAT number
FI25054582
EUDAMED status
Inactive since 2024
EUDAMED registered name
Elekta Oy
Registered address
12, Siltasaarenkatu, 00530, Helsinki, Finland
PRRC contact
Mooud Amirkavei(public in EUDAMED)

FDA recalls162

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 9
  • 2018 4
  • 2019 12
  • 2020 4
  • 2021 6
  • 2022 1
  • 2023 9
  • 2024 0
  • 2025 6
  • 2026 6

105 initiated before 2017

Showing the 10 most recent of 162 recalls.

  • 2026

    • 21 May 2026 Z-2406-2026 Class II Ongoing Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.via FDA establishment Elekta Inc. Distribution: Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of…
      Full distribution text Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
      Submission number: K223229
    • 3 Apr 2026 Z-2710-2026 Class II Ongoing Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
      Submission number: K132889
    • 3 Apr 2026 Z-2711-2026 Class II Ongoing Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
      Submission number: K161688
    • 3 Apr 2026 Z-2712-2026 Class II Ongoing Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
      Submission number: K201272
    • 19 Mar 2026 Z-2006-2026 Class II Ongoing Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.via FDA establishment Elekta Inc. Distribution: 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 SC TX UT VA WA WI WV OUS: Algeria…
      Full distribution text 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 SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
      Submission number: K190887
    • 18 Feb 2026 Z-1581-2026 Class II Ongoing Due to adapter not being properly aligned or locked in place.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
      Submission number: K250391

  • 2025

    • 14 Dec 2025 Z-1164-2026 Class II Ongoing Due to a manufacturing issue and electrical grounding of systems.via FDA establishment Elekta Inc. Distribution: Worldwide Submission number: K210500
    • 12 Dec 2025 Z-1339-2026 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
      Submission number: K151666
    • 12 Dec 2025 Z-1340-2026 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.
      Submission number: K173791
    • 10 Dec 2025 Z-1078-2026 Class II Ongoing 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 twicevia FDA establishment Elekta Inc. Distribution: US Nationwide distribution in the state of TX. Submission numbers: K203172, K223229
Show the 25 most recent of 162 recalls

  • 2025

    • 30 Sep 2025 Z-0433-2026 Class II Ongoing 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 woundvia FDA establishment Elekta Inc. Distribution: Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM,…
      Full distribution text Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
      Submission number: K190887
    • 15 Jan 2025 Z-1162-2025 Class II Ongoing Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.via FDA establishment Elekta Inc. Distribution: US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy…
      Full distribution text US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
      Submission number: K223229

  • 2023

    • 25 Oct 2023 Z-0442-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 25 Oct 2023 Z-0443-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 25 Oct 2023 Z-0444-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 25 Oct 2023 Z-0445-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 25 Oct 2023 Z-0446-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 25 Oct 2023 Z-0447-2024 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: worldwide Submission number: K210500
    • 5 May 2023 Z-1665-2023 Class II Ongoing A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601via FDA establishment Elekta Inc. Distribution: Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada,…
      Full distribution text Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.
      Submission number: K210500
    • 6 Apr 2023 Z-1675-2023 Class II Ongoing There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.via FDA establishment Elekta Inc. Distribution: US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX. Submission number: K212114
    • 28 Feb 2023 Z-1233-2023 Class II Ongoing Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.via FDA establishment Elekta Inc. Distribution: Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina,…
      Full distribution text Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Occupied, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sr…
      Submission number: K151233

  • 2022

    • 5 Dec 2022 Z-0719-2023 Class II Ongoing A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modelingvia FDA establishment Elekta Inc. Distribution: Distribution US nationwide, including Puerto Rico. There was no military/government distribution. Submission number: K132816

  • 2021

    • 13 Oct 2021 Z-0182-2022 Class II Ongoing Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.via FDA establishment Elekta Inc. Distribution: Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh,…
      Full distribution text Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam
      Submission number: K132816
    • 17 Sep 2021 Z-0116-2022 Class II Terminated 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.via FDA establishment Elekta Inc. Distribution: Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND,…
      Full distribution text Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND, MO, WA, OK, PR, NM, NC, ID, CT, DE, LA, MT, TN, CO, UT, MN, IN, RI, IA, DC, ND, AZ, HI, KS, NE, NH, AR, WY, WV, MS, VT and internationally to Albania, Antigua/Barbuda, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kyrgystan, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territor…
      Submission number: K210500
    • 14 Sep 2021 Z-2563-2021 Class II Ongoing 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.via FDA establishment Elekta Inc. Distribution: Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of PA, MI, WI, NY, TN, NJ, IA, TX and the countries of United Kingdom, Turkey, Switzerland, Sweden, Spain, Netherlands, Korea, Thailand, Japan, Italy, Hong Kong, Germany, France, Denmark, China, Canada, Belgium, Bahrain, Australia.
      Submission numbers: K183037, K190178

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Elekta Limited CRAWLEY West Sussex · GB FEI 3002806900
  • Elekta Inc. San Jose, CA · US FEI 3032638959

From the company website

Read 18 Oct 2026

Elekta helps clinicians treat cancer and brain disorders with radiation oncology. Explore radiotherapy systems, software and services worldwide.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Elekta Oy have in the registry?

The registry currently lists 1 device for Elekta Oy. Devices recorded under merged duplicate company entries are counted once.

Which registries list Elekta Oy's devices?

Among its 1 most recently registered device, Elekta Oy has devices listed in EUDAMED (1 device).

What risk classes do Elekta Oy's devices fall under?

Among its 1 most recently registered device, the classes recorded for Elekta Oy's devices are Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for Elekta Oy?

FDA recall records list 162 recalls initiated by Elekta Oy, the most recent initiated on 21 May 2026. 33 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Elekta Oy in the registry?

The most recently registered devices listed for Elekta Oy include Kaiku Health.

Which FDA establishments are linked to Elekta Oy?

2 FDA establishments are linked to Elekta Oy in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.