Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system. — recall Z-1501-2020
U.S. FDA — Device Enforcement · United States · 2020-02-10 · Class II
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Reported risk: The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.
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