medical Class II Updated 2021-04-14

Siemens Medical Solutions USA, Inc recalls Ysio X.pree, Model Number: 11107464 - Product Usage: A Digit

Recalled Product

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 / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045
View official government recall

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