Reflexion Medical, Inc. has recalled 12 units of the RefleXion X1 Radiotherapy System (Model RXM1000) due to a software defect. The defect occurs when medical staff perform angular roll corrections followed by a repeat localization, causing the system to fail to carry over initial corrections to the final treatment delivery. This can result in the radiation dose being delivered to the incorrect location, potentially missing the target by 5mm or more and causing a 10% to 20% underdose to the intended area. The affected systems include software versions 2.1.29-4 and 2.1.35-1.
If the software fails to apply the necessary alignment corrections, the radiation treatment may be delivered to the wrong anatomical location, leading to significant underdosing of the tumor and potential radiation exposure to healthy surrounding tissue.
Recall #: Z-1656-2026
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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