FDA-Device2020-02-26Class II
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF 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.
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
46
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF 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-1337-2020More Siemens Medical Solutions USA, Inc recalls
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