FDAJanuary 8, 2020device
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
What to do
FDA enforcement status: Terminated
Brands named
siemens medical solutionssiemenssiemens medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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