Elekta, Inc.
Elekta, Inc. appears in FDA public data with 116 recalls, 14 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2406-2026, Class II) was initiated on May 21, 2026. Its most recent 510(k) clearance was granted on March 29, 2019.
Summary
- Total Recalls
- 116
- 510(k) Clearances
- 14
- Inspections
- 11
- Compliance Actions
- 0
Known Names
elekta solutions, elekta, elekta limited, elekta instrument ab, elekta instrument, elekta solutions ab, elekta neuromag
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2406-2026 | Class II | MOSAIQ Oncology Information System | May 21, 2026 |
| Z-2712-2026 | Class II | Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inten | April 3, 2026 |
| Z-2710-2026 | Class II | Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading | April 3, 2026 |
| Z-2711-2026 | Class II | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr | April 3, 2026 |
| Z-2006-2026 | Class II | Brand Name: Leksell Vantage Arc System REF: 1053958 | March 19, 2026 |
| Z-1581-2026 | Class II | Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma | February 18, 2026 |
| Z-1164-2026 | Class II | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta | December 14, 2025 |
| Z-1340-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ver | December 12, 2025 |
| Z-1339-2026 | Class II | Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Ver | December 12, 2025 |
| Z-1078-2026 | Class II | MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) | December 10, 2025 |
| Z-0433-2026 | Class II | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software | September 30, 2025 |
| Z-1162-2025 | Class II | MOSAIQ Oncology Information System | January 15, 2025 |
| Z-0444-2024 | Class II | ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation T | October 25, 2023 |
| Z-0443-2024 | Class II | ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy Sy | October 25, 2023 |
| Z-0446-2024 | Class II | ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle | October 25, 2023 |
| Z-0445-2024 | Class II | ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accel | October 25, 2023 |
| Z-0447-2024 | Class II | ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerat | October 25, 2023 |
| Z-0442-2024 | Class II | ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiati | October 25, 2023 |
| Z-1665-2023 | Class II | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; | May 5, 2023 |
| Z-1675-2023 | Class II | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | April 6, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K190178 | Monaco RTP System | March 29, 2019 |
| K183034 | MOSAIQ Oncology Information System | December 4, 2018 |
| K183037 | Monaco RTP System | December 4, 2018 |
| K141855 | CLARITY | October 8, 2014 |
| K123808 | AGILITY | April 4, 2013 |
| K121663 | CLARITY | December 5, 2012 |
| K121328 | AGILITY | June 12, 2012 |
| K111332 | CLARITY OBP SYSTEM | January 30, 2012 |
| K102200 | INTEGRITY MODEL 1014284 | November 4, 2010 |
| K100115 | XVI R4.5 | March 10, 2010 |
| K082122 | MLCI2 | August 29, 2008 |
| K080585 | DESKTOP PRO | June 11, 2008 |
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 | August 12, 2005 |
| K042794 | BEAM MODULATOR, MODEL 4513 332 8000 | January 31, 2005 |