Siemens Medical Solutions USA, Inc recalls Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos
Recalled Product
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 / Issue
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.
Issued by
FDA
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