Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Recall date

December 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1078-2026

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

US Nationwide distribution in the state of TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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