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Recall Observatory FDA recall evidence

Device product

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

Z-1078-2026

December 10, 2025

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 98116
Status
Ongoing
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1078-2026

Official wording

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

Code information: 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 pattern: US Nationwide distribution in the state of TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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