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FDA-Device2026-01-21Class IIPROCESSING DEFECT

Elekta MOSAIQ Oncology System recalled for potential radiation overtreatment

Elekta
OTHERNationwide distribution

Check Elekta MOSAIQ particle therapy software

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
Hazard

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

Sold states
US Nationwide distribution in the state of TX.
Affected count
1
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2026

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