FDA (Devices) recall action 85999
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Siemens Medical Solutions is recalling 477 Luminos Agile Max units due to software defects that may cause system collisions or incorrect diagnostic images.
Siemens is recalling 194 Uroskop Omnia Max units due to software issues that may cause system collisions or incorrect diagnostic images.
Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.
Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.