A retrospective review was performed by agfa for events, from years 2012 to (b)(6) 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.The dealer reported to agfa that their customer had experienced an event in which their dx-d600 wall stand chest bucky had unintentionally moved into a patient's lap.There was no injury, but the customer did close the examination room.Agfa and (b)(4), agfa's supplier, investigated the event.Log files were reviewed and parts replaced on the wall stand.Additional upgrades were made to the system and system placed back into customer operation.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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