Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
US Nationwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2020