FDA-Device2020-02-26Class II
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.
Siemens Medical Solutions USA, Inc
Hazard
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Sold states
US Nationwide distribution.
Affected count
475
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2020Don't want to check this manually?
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