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.
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-1346-2021More Siemens Medical Solutions USA, Inc recalls
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