FDA-Device2021-04-14Class II

Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.

Siemens Medical Solutions USA, Inc
Hazard

A patient image was assigned to a different patient during image recovery process. In the unlikely event of interrupted connection to a MAX detector during initiated image recovery, instead of the currently acquired image, previously acquired image (potentially image of the previous patient) may be displayed to the user, potentially impact diagnosis of the patient examined when the connection was interrupted

Sold states
US Nationwide distribution in the states of FL, MN, OH, PA, TX.
Affected count
12 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2021

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