FDAJune 19, 2019device
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for iGUIDE to incorrectly monitor the 3D position.
What to do
FDA enforcement status: Terminated
Brands named
elekta
UPCs
040567190017040405671900174204056719002039
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMOSAIQ Oncology Information System2026-05-21
- FDABrand Name: Leksell Vantage Arc System REF: 10539582026-03-19
- FDABrand 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 s...2026-02-18
- FDABrand 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: No2025-12-14
- FDABrand 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.2025-12-12
- FDABrand 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.2025-12-12
- FDAMOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)2025-12-10
- FDABrand 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 ste...2025-09-30
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