[pending] MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Pending LLM rewrite. Source: FDA_DEVICE Z-1078-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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
The recalled product
- Product
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- MOSAIQ v 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
Distribution
Distributed nationwide across the United States.
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