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Recall Observatory FDA recall evidence

Device 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.

Z-1346-2021

March 10, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 87563
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-1346-2021

Official wording

Reason: 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

Code information: Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045

Distribution pattern: US Nationwide distribution in the states of FL, MN, OH, PA, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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