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 (b)(6) by the dealer in which their customer reported recurrence of uncontrolled movement of the wall bucky 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.In july 2014, a new software upgrade was performed on the system for this new event.The system has been corrected.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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