ProductGuru Recalls

Brand

Elekta, Inc.: official recall notices

8 official recall or safety notices published on this site name Elekta, Inc., dated between 2023-10-25 and 2025-12-12. They were issued by 1 authority: US FDA — Medical Devices (8).

Countries where the notices were issued: United States (8).

Name as written in the notices: Elekta, Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

What this page counts: the notices published as pages on product-guru.org, over every date (this site publishes a selection of the notices in the ProductGuru index). The brand scorecards count every indexed notice in a rolling 24-month window instead, so their totals differ from this page.

Notices by year

YearNotices
20252
20236

Notices by authority

AuthorityNotices
US FDA — Medical Devices8

All notices

DateAuthorityProductHazard (as classified)
2025-12-12US FDA — Medical DevicesBrand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Pr—
2025-12-10US FDA — Medical DevicesMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)—
2023-10-25US FDA — Medical DevicesELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S—
2023-10-25US FDA — Medical DevicesELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele—
2023-10-25US FDA — Medical DevicesELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear—
2023-10-25US FDA — Medical DevicesELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear—
2023-10-25US FDA — Medical DevicesELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li—
2023-10-25US FDA — Medical DevicesELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac—

All brands →