Elekta, Inc.
Elekta, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2019, with 113 FDA device recalls on record.
Top product codes for Elekta, Inc.
FDA recalls by Elekta, Inc.
10 most recent of 113- Z-2406-2026 — MOSAIQ Oncology Information System
- Z-2006-2026 — Brand Name: Leksell Vantage Arc System REF: 1053958
- Z-1581-2026 — Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
- Z-1164-2026 — Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
- Z-1339-2026 — Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
- Z-1340-2026 — 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 system designed for Leksell Gamma Knife¿ treatment planning.
- Z-1078-2026 — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Z-0433-2026 — Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Product Description: The Intended Purpose of Leksell¿ Vantage" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
- Z-1162-2025 — MOSAIQ Oncology Information System
- Z-0446-2024 — ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Elekta, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.