Elekta, Inc. recalls MOSAIQ Oncology Information System with Particle Therapy License

Recalling company

Elekta, Inc.

Product

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

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Dec 10, 2025

Reported

Jan 21, 2026

Distribution

US Nationwide distribution in the state of TX.

Status

Ongoing

Quantity

1

Lot / codes

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

Company location

Atlanta, GA

Recall type

Voluntary: Firm initiated

Recall number

Z-1078-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1078-2026 in the FDA Enforcement Report. Also see FDA recall press releases.