Siemens Medical Solutions USA, Inc recalls Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

Recall date

February 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1501-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.