Siemens Medical Solutions USA, Inc Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 manual, particularly in the chapter Safety , section Information about unit movements . Users and all accompanying personnel are advised to remain outside the zone of potential device movement, e.g., potential movement area of longitudinal and transversal direction of the ceiling stand. How will the corrective action be implemented and how effective is the corrective action? Siemens Healthineers is distributing a Customer Safety Advisory Letter XP046/20/S to all affected customers. A field software update for Ysio units that will eliminate the described issue will be distributed via an Update Instruction XP045/20/S. Apart from the described correction, the updated software contains further stability, usability, and performance improvements. This resolution will be provided free of charge and is planned to be available in the first quarter of calendar year 2022. Your local Siemens Healthineers Service organization will contact you as soon as the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800- 888-7436. Following the corrective action, the cause is eliminated and any recurrence of this potential fault is prevented Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisor