Siemens Medical Solutions USA, Inc recalls Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems u…

Recall date

August 6, 2018

Source

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

Recall number

Z-0299-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

The products were distributed to the following US states: AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NM, NV, NY, OH, OK, PA, PR, SC, SD, TX, UT, VA, WI, and WY.

Why it was recalled

In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope, which is not designed for continuous load and ongoing movement under load. This may lead to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning.

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 number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.