FDADecember 10, 2025device

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

elekta

UPCs

0734020150002607340201500071

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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