← Back to Medical Device Recalls
Recall Category: Medical Device Recalls
Recalling Firm: Elekta, Inc.
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
Classification: Class II
Status: Ongoing
Report Date: 01/21/2026
Recall Initiation Date: 12/10/2025
Distribution: US Nationwide distribution in the state of TX.
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
Product Quantity: 1
Recall Type: Voluntary: Firm initiated
Firm Location: Atlanta, GA, United States
Recall Number: Z-1078-2026
Event ID: 98116