Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 3/25/2020
Class II
PRODUCT
Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.
- Recall Number: Z-1501-2020
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 2/10/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
81 US/ 308 worldwide
DISTRIBUTION
US Nationwide