Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.
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
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions
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The recall affects the MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). The software versions involved include MOSAIQ v 3.10.200 and earlier versions up to v 3.2.3.1 with Particle Base. Distribution occurred nationwide in the United States, particularly Texas.
The oncology information system may lead to overtreatment if the plan is delivered with the Particle Therapy IHE-RO TDW-II interface. In certain scenarios, partial treatments can occur without proper checks, resulting in patients receiving excessive treatment doses.
No specific incidents or injuries have been reported directly related to this recall. However, the potential for serious health risks due to overtreatment exists.
Patients and healthcare providers should stop using the device immediately. Contact Elekta, Inc. or your healthcare provider for detailed instructions on how to proceed.
For more information, contact Elekta, Inc. at their official website or customer service line. You can also refer to the FDA recall report at the provided URL.
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