FDAJuly 26, 2021device
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
What to do
FDA enforcement status: Ongoing
Brands named
elekta
UPCs
0085816400219000858164002268
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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