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Siemens Medical Solutions USA, Inc Recall 87563

Description: 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 Recall 87563 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1346-2021
Event ID87563
Event DescriptionYsio 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.
Product TypeDevices
DistributionUS Nationwide distribution in the states of FL, MN, OH, PA, TX.
Quantity12 units
Recall ReasonA 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
Device Classification20210414
Device Code InfoSerial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045
Center Classification Date20210402
Recall Initiation Date20210310
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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