Elekta, Inc. — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
⚠️ 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
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 10, 2025
US Nationwide distribution in the state of TX.
What's affected?
- Product
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Brand
- Elekta, Inc.
- Lot code
- MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071
Additional details
MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base. Software Versions: 3.10.200, 3.1.1.0, 3.1.2.0, 3.1.3.0, 3.1.3.1, 3.1.3.2, 3.1.3.3, 3.1.3.4, 3.2.0.0, 3.2.1.0, 3.2.1.1, 3.2.1.2, 3.2.1.3, 3.2.1.4, 3.2.2.0, 3.2.2.1, 3.2.3.0, 3.2.3.1 UDI-DI: 07340201500026, 07340201500071
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1.
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