Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

On February 10, 2020, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed of the product issue, and instructed to take the following actions: When using the system, users should follow the regular cautions and instructions listed in the system operator manual, particularly in chapter Safety, section Information about unit movements. In addition, users and all accompanying personnel are to pay special attention to remain outside of the zone of potential device movement (hazardous zone), e.g., remain outside the possible movement area of longitudinal and transversal direction of the ceiling stand. Siemens Healthineers has issued a field software update that will eliminate the issue described. The resolution will be provided free of charge. The software update is already available and is being distributed. Your local Siemens Healthineers Service organization will contact you to schedule the software update for your system. To schedule an earlier appointment, you may contact the firm's service organization at 1-800-888-7436.