Recall Z-0730-2022 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
YSIO X.Pree
| Date | Mar 7, 2022 |
| Status | Open, Classified |
| Reason | For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparative stage for the entire examination area prior to the exam. During acquisition of each individual x-ray image, the x-ray collimator is automatically positioned in a way that the subsequent series of acquisition covers the defined field of view needed for each step. However, during the acquisition the collimation area displayed to the operator on the User Interface does not correctly represent the collimation area specified by the system. It indicates to the user an open collimator instead, e.g., th |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Advisory Notice to all affected customers. The letter inform customers that the firm will distribute a software correction via update instruction at no cost to the customers. |
| Quantity | 53 units |
| Distribution | US Nationwide, Worldwide distribution |
| 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 |