FDA-Device2026-01-21Class II
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta, Inc.
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
Sold states
US Nationwide distribution in the state of TX.
Affected count
1
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2026Don't want to check this manually?
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