Class IIOngoingZ-2406-2026
Elekta, Inc. recalls MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Elekta, Inc.GAJun 17, 2026
Elekta, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Class IIOngoingZ-2006-2026
Elekta, Inc. recalls Brand Name: Leksell Vantage Arc System REF: 1053958
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Elekta, Inc.GAMay 6, 2026
Class IIOngoingZ-1581-2026
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion L…
Due to adapter not being properly aligned or locked in place.
Elekta, Inc.GAMar 25, 2026
Class IIOngoingZ-1340-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1339-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1164-2026
Elekta, Inc. recalls Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy
Due to a manufacturing issue and electrical grounding of systems.
Elekta, Inc.GAFeb 4, 2026
Class IIOngoingZ-1078-2026
Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000…
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial trea…
Elekta, Inc.GAJan 21, 2026
Class IIOngoingZ-0433-2026
Elekta, Inc. recalls Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic Sys…
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Elekta, Inc.GANov 12, 2025
Class IIOngoingZ-1162-2025
Elekta, Inc. recalls MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Elekta, Inc.GAFeb 19, 2025