Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
What to do
FDA enforcement status: Ongoing
Brands named
Recall history
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