FDASeptember 24, 2019device
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
What to do
FDA enforcement status: Ongoing
Brands named
elekta impac softwareelektaelekta impac
UPCs
0085816400230500858164002312008581640023290085816400207700858164002084008581640020910085816400210700858164002220008581640020370085816400225100858164002282
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: 11.1 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: 11,3, 11.4 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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