FDA recall record · openFDA

Elekta, Inc.

18 FDA recalls on record (2023–2026) — 18 device. 18 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an un 6

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete r 2

Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Ther 1

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 1

Due to adapter not being properly aligned or locked in place. 1

Recalls

Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksel Class II 2026-02-18 MOSAIQ Oncology Information System Class II 2026-05-21 Brand Name: Leksell Vantage Arc System REF: 1053958 Class II 2026-03-19 MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Class II 2025-12-10 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr Class II 2025-12-12 MOSAIQ Oncology Information System Class II 2025-01-15 Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Class II 2025-12-12 Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version: n/a Produ Class II 2025-09-30 Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Class II 2025-12-14 ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S Class II 2023-10-25 ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele Class II 2023-10-25 ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Class II 2023-10-25 ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear Class II 2023-10-25 Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. El Class II 2023-05-05 Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy Class II 2023-02-28 ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li Class II 2023-10-25 ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac Class II 2023-10-25 Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. Class II 2023-04-06

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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