Elekta MOSAIQ Oncology System recalled for potential radiation overtreatment
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.
From the FDA notice · Read the official notice ↗ · All Elekta recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 1
- Illnesses reported
- None reported
- Manufactured in
- 400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
- Classification
- Class II
- Recall number
- Z-1078-2026
In the FDA's words
- Description
- MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) 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 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: US Nationwide distribution in the state of TX. Affected quantity: 1
- 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