FDA recall Z-1078-2026

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the state of TX.

Key facts

Status

Ongoing

Initiation date

2025-12-10

Report date

2026-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2026