medical Class II Updated 2022-04-06

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

Recalled Product

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 20113 23071 20118 22523 23021 22169 23164 22388 22119 22844 21209 23699 21114 22190 22146 22126 22128 22836 22163 22727 22135 22347 21174 22676 22029 22895 22917 22920 22058 22847 22852 22655 22708 22275 22254 22928 22857 22208 22071 23130 22092 22175 21194 23602 23018 23019 22076 22630 21108 22919 22825 22054 22177 20105 22998 20115 22104 22966 23625 23627 22748 22352 22353 22354 22618 21004 21005 22136 23059 22914
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