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.The customer reported to agfa on (b)(6) 2014, when using their dx-d600 system in preparation of a patient exam, they experienced uncontrolled automated vertical movement of the wallstand - overhead tube crane (otc).While holding onto the "ferrari wheel", rapid unexpected movement, of the otc, caused the operator to lose her balance and twist her left shoulder.As reported by the customer, no surgical intervention was required.Agfa service was on site the next day, (b)(4) 2014, and the same operator was working normal hours.Agfa continued the investigation the same day by obtaining log files and disabling the auto positioning.The customer was able to use the system until the system upgrade to version 3.6 was performed.There were no further reports of harm to any other patients or users during this event.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.
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