Elekta MOSAIQ Oncology System Recall
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Updated December 10, 2025
Elekta's MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) may deliver radiation treatment twice instead of once in certain conditions, resulting in overtreatment. The system can fail to verify that partial treatments have already been delivered, causing duplicate doses.
Is the Elekta, Inc. recalled? Yes. This product was recalled by FDA on December 10, 2025. Details below.
What is recalled
MOSAIQ Oncology Information System with Particle Therapy License, specifically License Kit 45700000000IQRO
Am I affected
You're affected if your cancer treatment center uses Elekta's MOSAIQ Oncology Information System with the Particle Therapy License Kit 45700000000IQRO, particularly if your treatment plan involves the Particle Therapy IHE-RO TDW-II interface and uses one field per fraction or partial treatments with field interruptions.
What to do right now
Contact Elekta, Inc. immediately to report whether your facility uses this system and obtain guidance on preventing duplicate treatment delivery. Do not proceed with new treatment plans until your facility has been advised by the manufacturer on how to safely operate this system.
The hazard
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 treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1078-2026
- Classification
- Class II
- Recalled
- December 10, 2025
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