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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1346-2021 |
| Event ID | 87563 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, MN, OH, PA, TX. |
| Quantity | 12 units |
| Recall 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 |
| Device Classification | 20210414 |
| Device Code Info | Serial Numbers: 10041 10046 10055 10057 10053 10049 10043 10039 10054 10048 10042 10045 |
| Center Classification Date | 20210402 |
| Recall Initiation Date | 20210310 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
| Similar To |