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.
Siemens Medical Solutions USA, Inc
Hazard
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
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-1331-2020Don't want to check this manually?
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