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Siemens Medical Solutions USA, Inc recalls The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body
Recalled October 1, 2014 · FDA recall Z-2680-2014 · Siemens Medical Solutions USA
Hazard
Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated. · FDA Class II
Units
62
Sold at
Nationwide Distribution.
Description
Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.
Product
The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →