MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 10, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | Elekta, Inc. |
| Country / region | United States GA |
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
Affected products
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
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