A retrospective review was performed by agfa for events, from (b)(6), 2015, related to unexpected movement of dx-d600 systems.Vigilance activity to report identified events was implemented (b)(6) 2015.The following event was identified and is being reported to the fda.The dealer was onsite and observed unexpected overhead tube crane (otc) movement of the customer's dx-d600.In moving the otc a little upwards the wall stand raced to the top of the stand at high speed and crashed into the top.The dealer rebooted the entire system and the problem still occurred.The dealer recalibrated the wall stand position and velocity.The system tested okay after this.The dealer obtained the nova log files and configuration for investigation.Updates and part exchanges were performed on this system in november/december 2013, with assistance from (b)(4), agfa's supplier, and the wall stand was replaced.In (b)(6) 2014, a new software upgrade was 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 (b)(6), 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 (b)(6), 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.
|