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 MOSAIQ Oncology Information System is designed to manage workflow in oncology treatment settings. Healthcare providers use it to ensure accurate administration of cancer therapies, including particle therapy.
The system's software may incorrectly handle treatment plans, leading to potential overtreatment if proper checks are not conducted. This flaw can result in patients receiving more treatment than necessary, posing serious health risks.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers' ability to deliver safe treatments, potentially delaying patient care and requiring adjustments to workflows.
Serial numbers and software versions can typically be found in the system settings or on the device's identification label.
Expect a response from Elekta regarding the recall instructions within a few days of reporting.
Keep records of all communications regarding the recall, including emails, phone calls, and any correspondence received from Elekta.
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.
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