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

Recalled April 6, 2022 · FDA recall Z-0841-2022 · Siemens Medical Solutions USA

Hazard
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. · FDA Class II
Units
70 Systems
Sold at
US Nationwide.

Description

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.

Product
Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system
Manufacturer(s)
Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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