Elekta, Inc. has recalled one unit of the MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO). The recall affects software versions 3.10.200 and 3.1.1.0 through 3.2.3.1 that use the Particle Therapy IHE-RO TDW-II interface. A software error can cause a partial radiation dose to be delivered twice if a treatment is interrupted and manually recorded, leading to patient overtreatment.
The software fails to correctly check the radiation meterset value after a treatment interruption, which may result in a patient receiving double the intended partial dose of radiation. Excessive radiation exposure can lead to serious health complications, including radiation-induced tissue damage or other long-term injuries.
Affected software versions include 3.10.200 and the range from 3.1.1.0 up to and including 3.2.3.1 with Particle Base.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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