Elekta, Inc.: MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Reason / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of TX.
- Recall initiated
- 2025-12-10
- Code info
- 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
- Product quantity
- 1
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Atlanta
- State
- GA
- Country
- United States
- Event id
- 98116
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