Reflexion Medical, Inc. has recalled 11 units of the RefleXion X1 (Model RXM1000) radiation therapy system due to a software configuration error. This error may allow the device to deliver more than two radiation treatments (fractions) within a single 12-hour period, which exceeds the intended safety limits. The affected systems were distributed in California, Connecticut, Louisiana, New Jersey, Oregon, Pennsylvania, and Texas. Facilities using these systems should contact the manufacturer to arrange for a software correction to prevent potential injuries.
Delivering radiation treatments too close together can cause radiation toxicity. This excessive exposure may lead to serious adverse health events for patients undergoing cancer treatment.
The RefleXion X1 is a radiation therapy system that combines emission computed tomography detection with a linear accelerator for oncologic treatment.
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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