FDAFDA · Food and drugs·Recall number Z-1078-2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Published January 21, 2026 · Recall initiated: December 10, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- US Nationwide distribution in the state of TX.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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