Reported Jan 21, 2026 · Ongoing
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Lot codes and dates
- MOSAIQ v 3.10.200, and 3.1.1.0 up to and including v 3.2.3.1 with Particle Base
- Software Versions
3.10.2003.1.1.03.1.2.03.1.3.03.1.3.13.1.3.23.1.3.33.1.3.43.2.0.03.2.1.03.2.1.13.2.1.23.2.1.33.2.1.43.2.2.03.2.2.13.2.3.03.2.3.1
- UDI-DI
0734020150002607340201500071
- Amount recalled
- 1
Where it was sold
- Nationwide
- TX
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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