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Siemens Medical Solutions USA, Inc recalls Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Recalled March 25, 2020 · FDA recall Z-1501-2020 · Siemens Medical Solutions USA
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. · FDA Class II
Units
81 US/ 308 worldwide
Sold at
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.
Description
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.
Product
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →