Serious health risk
⚠ This recall is currently active
Elekta, Inc.
Devices recall · Z-1078-2026
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
Product description
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Recalling firm
Elekta, Inc.
Product quantity
1
Lot / code info
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
Distribution
US Nationwide distribution in the state of TX.
Recall initiated
2025-12-10
Status
Ongoing
Location
Atlanta, GA, United States
Voluntary / mandated
Voluntary: Firm initiated
Data from official federal safety records. Updated periodically. Verify on FDA.gov