Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/6/2022
Class II
PRODUCT
Ysio system with VC10 software version, Model Number 10281013. Radiographic system
Recall Number:
Z-0841-2022
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.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 2/3/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
70 Systems
DISTRIBUTION
U.S. Nationwide