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Siemens Medical Solutions USA, Inc recalls Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical st
Recalled February 26, 2020 · FDA recall Z-1338-2020 · Siemens Medical Solutions USA
Hazard
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis. · FDA Class II
Units
475
Sold at
US Nationwide distribution.
Description
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →