Elekta, Inc. recalls
Every recall we track for Elekta, Inc. — 49 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
49 recalls since 2017.
All FDA recall records for Elekta, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 3 | 1 | 5 |
| 2018 | 0 | 2 | 1 | 1 | 4 |
| 2019 | 0 | 2 | 6 | 1 | 9 |
| 2020 | 0 | 1 | 2 | 0 | 3 |
| 2021 | 0 | 1 | 3 | 2 | 6 |
| 2022 | 0 | 0 | 0 | 1 | 1 |
| 2023 | 0 | 5 | 2 | 2 | 9 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 3 | 2 | 1 | 6 |
| 2026 (to date) | 0 | 3 | 1 | 2 | 6 |
What to do if you have a recalled Elekta, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Elekta, Inc. recalls
40 shown- Lower riskMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System
Elekta recalls MOSAIQ Oncology Information System software version 3.2 due to potential failure to load adapted baseline shift plans during treatment, risking incorrect radiation therapy delivery.
ElektaMay 21, 2026 - UnratedMedical device
Elekta, Inc. recalls Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product
Elek: Recall of Fletcher CT/MR Shielded Applicator Set due to potential IU tube detachment after use. Affected units may cause retained tissue in patients.
ElektaApr 3, 2026 - Use cautionMedical device
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Elekta recalls Leksell Vantage Arc System devices with potential shifting coordinates during procedures. Affected units have specific serial numbers and lot codes. Contact Elekta for remedy details.
ElektaMar 19, 2026 - Use cautionMedical device
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell
Elekta recalls Leksell Gamma Knife Perfexion and Icon models with adapter not properly aligned or locked, posing a risk of improper function during radiosurgery procedures.
Leksell Gamma KnifeFeb 18, 2026 - Use cautionMedical device
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Elekta recalls Synergy, Harmony, Infinity, and Versa HD linear accelerators due to electrical grounding issues. Affected units may have safety risks during medical treatments.
ElektaDec 14, 2025 - Use cautionMedical device
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4
Elekta recalls Leksell GammaPlan radionuclide RT treatment planning software versions 11.3 and 11.4 due to potential risk of irradiating the wrong patient location during treatment planning.
ElektaDec 12, 2025 - Lower riskMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta recalls specific versions of MOSAIQ Oncology Information System with Particle Therapy License due to potential for repeated partial treatments causing overtreatment. Affected software versions include 3.10.200 to 3.2.3.1.
ElektaDec 10, 2025 - Lower riskMedical device
Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product
Elekta recalls Leksell Vantage Stereotactic System due to risk of paint flakes separating and entering surgical wounds during neurosurgery. Affected units have specific serial numbers.
ElektaSep 30, 2025 - UnratedMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System
Elekta recalls specific versions of its MOSAIQ Oncology Information System software due to potential incorrect image offsets for Linear Accelerators not characterized at IEC61217 scale.
ElektaJan 15, 2025 - Use cautionMedical device
Elekta, Inc. recalls ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy
Elekta recalls specific models of Infinity radiation therapy systems due to potential uncontrolled extension of detector arms if microswitch is incorrectly set up. Affected units include serial numbers starting with 152596 to 154565.
ElektaOct 25, 2023 - UnratedMedical device
Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta
Elekta recalls specific models of medical linear accelerators due to a component non-compliant with IEC 60601 standards. Affected units include Elekta Infinity, Versa HD, and Elekta Synergy with specific serial numbers.
ElektaMay 5, 2023 - Lower riskMedical device
Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Elekta recalls Unity Image-Guided Radiation Therapy Systems with a potential overheating electrical connector in the MR gradient coil. This low-risk issue may require monitoring but does not mandate immediate action.
ElektaApr 6, 2023 - UnratedMedical device
Elekta Inc recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Elekta recalls Monaco RTP System software versions 5.11.00-5.11.03 due to potential inaccurate radiation dose calculations in treatment plans. Affected users should contact Elekta for details.
ElektaFeb 28, 2023 - UnratedMedical device
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
Elekta recalls Oncentra Brachy radiation therapy software versions 4.0+ with reconstruction errors in Catheter Bending features. Affected units have specific UDI GTIN numbers listed. No remedy provided in official notice.
ElektaDec 5, 2022 - UnratedMedical device
Elekta, Inc. recalls Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Elekta recalls Oncentra Brachy software versions 4.0 and above with specific Applicator Modeling license (170283-00) due to potential dose delivery differences between planned and actual radiation treatment.
ElektaOct 13, 2021 - Use cautionMedical device
Elekta, Inc. recalls Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta
Elekta recalls specific medical linear accelerators due to risk of diode failure when removed, potentially causing injury. Affected models include Precise Digital, Harmony, Synergy, Infinity, and Versa HD systems.
ElektaSep 17, 2021 - Lower riskMedical device
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation
Elekta recalls Monaco radiation treatment software versions 5.40.00-5.40.02 and 5.51.10 due to potential unintended contour changes saving image sets, which could affect radiation treatment plans.
ElektaSep 14, 2021 - Lower riskMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System
Elekta recalls MOSAIQ Oncology Information System software version 2.83 where drug strength settings may revert to original after ordering changes. Affected units run with First Data Bank (FDB) and have specific UDI/GTIN numbers.
ElektaSep 2, 2021 - Lower riskMedical device
Elekta Inc recalls Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Elekta recalls Monaco RTP System software builds 5.40.00-5.51.10 due to potential dose calculation errors if couch is removed and added during plan loading. Affected users should contact Elekta for details.
ElektaJul 26, 2021 - UnratedMedical device
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
Elekta recalls specific versions of its MOSAIC Oncology Information System (2.62, 2.64, 2.70, 2.81, 2.82, 2.83) hosted on Classic Cloud due to malware vulnerability. Affected users should check their version numbers and contact support.
ElektaApr 20, 2021 - Lower riskMedical device
Elekta, Inc. recalls Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation
Elekta recalls Unity radiation therapy systems with serial numbers 600001-600043 due to potential Legionella in heat exchanger condensation tray. Affected units may need cleaning or inspection.
ElektaApr 30, 2020 - Lower riskMedical device
Elekta Inc recalls Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to
Elekta recalls Monaco RTP radiation treatment software version 5.40.00 and 5.40.01 due to potential inaccurate radiation dose delivery. Affected users should contact Elekta for details.
ElektaApr 16, 2020 - Use cautionMedical device
Elekta Inc recalls Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological
Elekta recalls Leksell Vantage Stereotactic System Instrument Carrier (serial numbers SH00106 to SH00178) due to a faulty locking piece that may not secure properly to the Arc system.
ElektaMar 30, 2020 - Use cautionMedical device
Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System
Elekta recalls specific Unity radiation therapy systems due to reported excessive heating in the MRL Gradient Connection Module. Affected units have serial numbers starting with 600014 to 600035. Contact Elekta for details.
ElektaDec 18, 2019 - Lower riskMedical device
Elekta Inc recalls Monaco Radiation Treatment Planning System (RTP) System
Elekta recalls Monaco radiation treatment planning software builds 5.40.00, 5.50.00, and 5.51.00 due to incorrect energy optimization during dose calculations. Affected users should contact Elekta for remediation.
ElektaNov 22, 2019 - Lower riskMedical device
Elekta Inc recalls Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make
Elekta recalls Monaco RTP System software versions 5.50 and 5.51 due to potential incorrect radiation dose calculations, which could affect cancer treatment safety. Affected users should contact Elekta for details.
Elek: The Monaco RTP SystemSep 4, 2019 - UnratedMedical device
Elekta, Inc. recalls Monaco Radiation Treatment Planning System (RTP) System
Elekta recalls Monaco radiation treatment software versions 5.50.00 and 5.51.00 due to incorrect anatomy and beam shift display in reports, which could lead to improper radiation targeting.
Elek: The brand name from the manufacturer title isAug 23, 2019 - Use cautionMedical device
Elekta Inc recalls Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
Elekta recalls Monaco RTP software versions 5.10 and 5.11 due to potential incorrect monitor unit scaling during radiation treatment planning. Affected units may require software update to prevent treatment errors.
ElektaJul 3, 2019 - Lower riskMedical device
Elekta, Inc. recalls Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for
Elekta recalls Unity radiation therapy systems due to QA software not displaying MR to MV offset values, risking treatment errors. Affected units include specific model numbers and installation dates.
ElektaJun 24, 2019 - Lower riskMedical device
Elekta, Inc. recalls iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Elekta recalls iGUIDE System software versions 2.2.0-2.2.2 due to potential incorrect 3D position monitoring. Affected units have specific GTIN numbers and were sold with these software builds.
ElektaJun 19, 2019 - Lower riskMedical device
Elekta, Inc. recalls Monaco Radiation Treatment Planning (RTP) System
Elek: Monaco radiation treatment software version 5.40 may use incorrect dose optimization models during plan adaptation. Affected users should contact Elekta for details.
ElektaFeb 8, 2019 - Use cautionMedical device
Elekta, Inc. recalls MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for
Elekta recalls MOSAIQ Oncology Information System and Sequencer versions 1.0+ and 6.1+ due to potential overdose from missing wedge IDs in radiation treatment plans.
ElektaDec 13, 2018 - UnratedMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for
Elekta recalls MOSAIQ Oncology Information System Version 2.64 due to potential incorrect isocenter settings when copying treatment fields, which could affect radiation therapy accuracy.
ElektaDec 4, 2018 - Lower riskMedical device
Elekta, Inc. recalls MOSAIQ Oncology Information System
Elekta recalls MOSAIQ Oncology Information System software builds 2.64 SP3 and higher due to order status not updating correctly after completion. Affected users should contact support for updates.
ElektaAug 3, 2018 - Use cautionMedical device
Elekta, Inc. recalls HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage:
Elekta recalls HexaPOD evo RT Couch Top (HexaPOD evo Module) due to potential incorrect patient positioning after 6D radiation therapy workflows. Affected units have specific serial numbers.
ElektaMay 16, 2018 - Use cautionMedical device
Elekta, Inc. recalls ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise
Elekta recalls Synergy, Synergy S, Synergy Platform, Precise, Infinity, Axesse, and Versa HD digital accelerators due to potential uncontrolled extension of iViewGT/XVI detector arms. Affected units may require repair or replacement.
Elek:taDec 1, 2017 - Lower riskMedical device
Elekta Inc recalls Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Elekta recalls ERGO++ software version 1.7.3+ for stereotactic treatments due to incorrect DICOM mapping of collimator/couch angles, potentially causing inaccurate radiation therapy planning.
Elek:taSep 1, 2017 - UnratedMedical device
Elekta, Inc. recalls MOSAIQ Medical Charged-Particle Radiation Therapy System
Elek: Recalls all MOSAIQ Medical Charged-Particle Radiation Therapy System software builds due to risk of incorrect radiation targeting during treatment. No remedy specified.
ElektaJun 30, 2017 - Lower riskMedical device
Elekta, Inc. recalls MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information
Elekta recalls MOSAIQ Oncology Information System versions 2.50.05+ due to outdated information retention in order sets, potentially affecting treatment planning accuracy.
ElektaJun 21, 2017 - Lower riskMedical device
Elekta, Inc. recalls iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a
Elekta recalls iGUIDE Software 2.2 versions due to incorrect PEC values that could affect patient positioning accuracy in radiotherapy. Affected units include iGUIDE 2.2.0 and 2.2.1.
ElektaJun 19, 2017
Elekta, Inc. recall questions
How many recalls has Elekta, Inc. had?
49 recalls from Elekta, Inc. are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Elekta, Inc. recall?
Elekta, Inc. recalls MOSAIQ Oncology Information System, dated May 21, 2026. Every Elekta, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Elekta, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Elekta, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.