FDA-Device2022-04-13Class II

YSIO X.Pree

Siemens Medical Solutions USA, Inc
Hazard

For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., the information displayed on the User Interface shows wider area of collimation than values preset prior to the examination. However, the collimation of the x-ray is performed correctly and always matches the examination area predefined by the user.

Sold states
US Nationwide, Worldwide distribution
Affected count
53 units
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
YSIO X.Pree

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0730-2022

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