Recall Z-1346-2021 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
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.
| Date | Mar 10, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. issued Customer Safety Advisory Notice to customers via XP051/20/S on 3/10/21. Letter states reason for recall, health risk and action to take: It is advised for the user to check the image displayed following image recovery to ensure that it is a newly acquired image of the current patient. If the operator detects the error, the image should be deleted, and Siemens Customer Service should be notified. Siemens Healthineers will provide a field software update VA10D for YSIO X.pree units that will eliminate the issue described. The software update will be d |
| Quantity | 12 units |
| Distribution | US Nationwide distribution in the states of FL, MN, OH, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201670 | YSIO X.pree Siemens Medical Solutions USA, Inc., Oct 21, 2020 |