medical Class II Updated 2022-04-13

Siemens Medical Solutions USA, Inc recalls YSIO X.Pree

Recalled Product

YSIO X.Pree


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 11107464
View official government recall

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