Reflexion Medical, Inc. has recalled 7 units of the RefleXion X1 Radiotherapy System (Model RXM1000) running software version 2.1.19-3. This specialized system, which combines imaging with a linear accelerator, has a software defect that can cause a potential dose error for patients receiving specific radiotherapy treatments. The issue occurs when patients are treated with an 'out of session SCINTIX partial fraction,' which could result in the patient receiving an incorrect amount of radiation during their therapy session. These systems were distributed in California, Connecticut, New Jersey, Oregon, Pennsylvania, and Texas.
The software defect may lead to patients receiving an incorrect dose of radiation during treatment. Inaccurate radiation delivery can compromise the effectiveness of cancer treatment or cause unintended exposure to healthy tissues, potentially leading to treatment complications.
Manufacturer Notification and Technical Guidance
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.
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Sources: FDA iRES · Raw API Response
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