This recall affects Siemens Medical Solutions LUMINOS Lotus Max (Model 11574100) and Luminos dRF Max (Model 10762471) diagnostic systems running software version VF11. Only 1 unit is affected in the United States, along with 95 units internationally. The systems may fail to align the X-ray beam correctly (collimation) if the operator switches quickly between different organ programs, which could lead to inaccurate medical images or unnecessary radiation exposure. Users should contact the manufacturer to arrange for a software correction.
A collimation error can result in an incorrect X-ray beam size or position during medical imaging. This poses a risk of poor image quality that could lead to diagnostic errors, or it may expose the patient to unintended radiation.
Affected systems feature a bucky wall stand for mobile detectors and are without a ceiling stand.
Affected systems feature a bucky wall stand for mobile detectors and are without a ceiling stand.
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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