--- title: "Elekta, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Elekta, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/elekta-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Elekta, Inc. recall records **23** reported ongoing 23 records in this archive. Latest source date May 21, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 21, 2026 FDA device enforcement ### [MOSAIQ Oncology Information System](https://isitonrecall.com/recall/fda-device-z-2406-2026-mosaiq-oncology-information-system/) Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. Class II Reported ongoing Distribution: 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... [Official source for MOSAIQ Oncology Information System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2406-2026%22) Apr 3, 2026 FDA device enforcement ### [Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is ...](https://isitonrecall.com/recall/fda-device-z-2710-2026-brand-name-fletcher-ct-mr-shielded-applicator-set-product-name-intracavitary-remote-afterloading-app/) Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Class II Reported ongoing Distribution: 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, O... [Official source for Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloadin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2710-2026%22) Apr 3, 2026 FDA device enforcement ### [Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavit...](https://isitonrecall.com/recall/fda-device-z-2711-2026-brand-name-brachytherapy-applicator-product-name-advanced-gynecological-applicator-product-descripti/) Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Class II Reported ongoing Distribution: 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, O... [Official source for Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Desc...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2711-2026%22) Apr 3, 2026 FDA device enforcement ### [Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the ...](https://isitonrecall.com/recall/fda-device-z-2712-2026-brand-name-geneva-product-name-brachytherapy-applicator-product-description-the-device-is-intended-f/) Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Class II Reported ongoing Distribution: 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, O... [Official source for Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inte...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2712-2026%22) Mar 19, 2026 FDA device enforcement ### [Brand Name: Leksell Vantage Arc System REF: 1053958](https://isitonrecall.com/recall/fda-device-z-2006-2026-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. Class II Reported ongoing 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 Australia Austria Azerbaijan Belgium China Colombia Costa Rica C... [Official source for Brand Name: Leksell Vantage Arc System REF: 1053958](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2006-2026%22) Feb 18, 2026 FDA device enforcement ### [Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available...](https://isitonrecall.com/recall/fda-device-z-1581-2026-brand-name-leksell-gamma-knife-product-description-leksell-gamma-knife-perfexion-leksell-gamma-knife/) Due to adapter not being properly aligned or locked in place. Class II Reported ongoing Distribution: 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, R... [Official source for Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1581-2026%22) Dec 14, 2025 FDA device enforcement ### [Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear A...](https://isitonrecall.com/recall/fda-device-z-1164-2026-brand-name-elekta-medical-linear-accelerator-product-name-elekta-synergy-elekta-harmony-elekta-infin/) Due to a manufacturing issue and electrical grounding of systems. Class II Reported ongoing Distribution: Worldwide [Official source for Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekt...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1164-2026%22) Dec 12, 2025 FDA device enforcement ### [Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system d...](https://isitonrecall.com/recall/fda-device-z-1339-2026-brand-name-leksell-gammaplan-product-name-radionuclide-rt-treatment-planning-system-software-version/) 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 e... Class II Reported ongoing Distribution: 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, T... [Official source for Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ve...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1339-2026%22) Dec 12, 2025 FDA device enforcement ### [Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based sy...](https://isitonrecall.com/recall/fda-device-z-1340-2026-brand-name-leksell-gammaplan-product-name-radionuclide-rt-treatment-planning-system-software-version/) 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 e... Class II Reported ongoing Distribution: 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, T... [Official source for Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ve...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1340-2026%22) Dec 10, 2025 FDA device enforcement ### [MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)](https://isitonrecall.com/recall/fda-device-z-1078-2026-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 treatment occurs followed by treatment fi... Class II Reported ongoing Distribution: US Nationwide distribution in the state of TX. [Official source for MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1078-2026%22) Sep 30, 2025 FDA device enforcement ### [Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" St...](https://isitonrecall.com/recall/fda-device-z-0433-2026-brand-name-leksell-stereotactic-system-product-name-leksell-vantage-stereotactic-system-software-ver/) 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 Class II Reported ongoing 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, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The cou... [Official source for Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Softwar...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0433-2026%22) Jan 15, 2025 FDA device enforcement ### [MOSAIQ Oncology Information System](https://isitonrecall.com/recall/fda-device-z-1162-2025-mosaiq-oncology-information-system/) Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. Class II Reported ongoing Distribution: 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 Af... [Official source for MOSAIQ Oncology Information System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1162-2025%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0442-2024-elekta-limited-precise-digital-accelerator-ref-mrt-6001-mrt-6011-medical-charged-particle-radiation/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0442-2024%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0443-2024-elekta-limited-elekta-synergy-ref-mrt-8501-mrt-8511-medical-charged-particle-radiation-therapy-syste/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0443-2024%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0444-2024-elekta-limited-elekta-synergy-platform-ref-mrt-8501-mrt-8511-medical-charged-particle-radiation-ther/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiatio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0444-2024%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0445-2024-elekta-limited-versa-hd-ref-xrt-2121-2131-medical-charged-particle-radiation-therapy-system-accelera/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Ac...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0445-2024%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0446-2024-elekta-limited-elekta-infinity-ref-xrt-0511-xrt-0521-xrt-0531-xrt-0541-medical-charged-particle-radi/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Parti...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0446-2024%22) Oct 25, 2023 FDA device enforcement ### [ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear](https://isitonrecall.com/recall/fda-device-z-0447-2024-elekta-axesse-ref-xrt-2181-xrt-27891-medical-charged-particle-radiation-therapy-system-accelerator-l/) 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. Class II Reported ongoing Distribution: worldwide [Official source for ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Acceler...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0447-2024%22) May 5, 2023 FDA device enforcement ### [Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy](https://isitonrecall.com/recall/fda-device-z-1665-2023-elekta-medical-linear-accelerator-elma-included-in-the-below-platforms-a-elekta-infinity-b-versa-hd/) A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 Class II Reported ongoing Distribution: 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, ... [Official source for Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1665-2023%22) Apr 6, 2023 FDA device enforcement ### [Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.](https://isitonrecall.com/recall/fda-device-z-1675-2023-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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX. [Official source for Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1675-2023%22) ## Reasons in these listed records - Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. - Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. - Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. - Due to adapter not being properly aligned or locked in place. These examples come from this result page and are not a ranking of every recall reason. ## Checking Elekta, Inc. ### Is there a recall on elekta, inc. right now? This archive contains 23 records, including 23 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Elekta, Inc.](https://isitonrecall.com/check/?q=Elekta%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)