A retrospective review was performed by agfa for events, from years 2012 to march 20, 2015, related to unexpected movement of dx-d600 systems.Vigilance activity to report identified events was implemented march 2015.The following event was identified and is being reported to the fda.A complaint was opened january 5, 2014 by the dealer in which their customer reported uncontrolled movements of the wall stand of the dx-d600 system.Updates and part exchanges had already been performed on this system in november/december 2013, with assistance from (b)(4), agfa's supplier, and the wall stand had been replaced.In this event, there was fast upward movement of the wall stand bucky to the top of its travel when auto-centering was selected from the control panel and there was fast downward movement to the bottom of the wall stand travel when the overhead tube crane (otc) was moved up slightly.Log files were obtained for investigation and the system was configured to work in only manual mode.Auto tracking and auto positioning switches were disabled in the nova service software.By january 8, 2014, agfa and (b)(4) were able to have the system back up and running for customer use.In july 2014, a new software upgrade was also performed on the system.Agfa has initiated the following corrective actions related to unintended movement of dx-d600 systems to address these unexpected movements.On july 2, 2014, vigilance activity was initiated to report corrections to fda (fda # z-2175-2014) for a mandatory software upgrade of dx-d600 full automatic systems to version 3.6 to prevent unexpected system movements.On december 15, 2014, vigilance activity was also initiated to report additional corrections to fda in the same (fda # z-2175-2014) to implement the mandatory upgrade of semi-automatic dx-d600 systems to version 3.6 to prevent unexpected system movements and to implement the mandatory upgrade of analog manual dx-d600 systems to an improved detent fixation.There were no reports of harm to any patients or users.
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