C-RAD POSITIONING AB is recalling Catalyst and Catalyst+ patient positioning systems, specifically 189 units using the cSRS software module in combination with the cMotion module. The system may incorrectly indicate that a patient is properly aligned for stereotactic radiosurgery (SRS) even when their position is outside of the safe tolerance limits. Consumers should contact the manufacturer or their healthcare facility supervisor to address this software issue.
If a patient is incorrectly positioned during radiotherapy, the treatment may be delivered to the wrong area. This could lead to radiation damage to healthy tissue or an ineffective treatment of the target area.
The error is not related to any serial numbers or LOT numbers; it is limited to the software module cSRS in combination with cMotion module.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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