Elekta MOSAIQ Oncology System recalled for potential radiation overtreatment
What this means
Certain versions of Elekta's MOSAIQ oncology information system may deliver twice the intended radiation dose to cancer patients under specific conditions involving partial treatments and interrupted fields. This could occur when the system fails to verify the correct dose amount after a treatment interruption. The issue affects systems using particle therapy with certain software versions.
- If your facility uses MOSAIQ with Particle Therapy License (Kit 45700000000IQRO), contact Elekta immediately
- Verify your software version against the affected list (3.10.200 through 3.2.3.1)
- Do not resume particle therapy treatments until Elekta confirms your system is safe or provides a fix
- Review recent treatment records for patients who received interrupted partial treatments
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2026Want us to check the next one for you?
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