Recall Z-0841-2022 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
| Date | Jan 31, 2022 |
| Status | Open, Classified |
| Reason | Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons. |
| Root cause | Software design |
| Action | An URGENT: MEDICAL DEVICE CORRECTION dated 1/31/22 was sent to customers. What is the impact on system operation and what are the potential risks? If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons. What steps can the user take to avoid the potential risks associated with this issue? It is highly improbably that the user will experience the described issue. However, it is recommended to follow regular cautions and instructions listed in the system operator man |
| Quantity | 70 Systems |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081722 | YSIO Siemens Medical Solutions USA, Inc., Aug 22, 2008 |