FDA-Device2020-03-25Class II
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Siemens Medical Solutions USA, Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of AR, CA, DC, FL, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, UT, VA and WI.
Affected count
81 US/ 308 worldwide
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1501-2020Don't want to check this manually?
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