This medial device report is being submitted due to a recent fda inspection held at agfa's (b)(4) location.It was determined that 17 additional occurrences identified with the same event issue as described in mdr report, fda # 9616389-2013-00003, but at different sites, required reporting to document the additional occurrences.This report is for a 8th event in which a agfa customer support engineer informed agfa on (b)(4) 2013, that the site had experienced their dx-d100 unit exhibiting erratic movement when driving the unit and that the unit had actually bumped into a site technologist.No harm has been reported for this event.The agfa cse replaced the digital motion control board, gauges and adjusted voltages.The dx-d100 unit for this site is now working as expected.Agfa investigation was already underway for a reportable correction to the fda on (b)(4).For the corrections, agfa implemented mandatory service bulletins in which all affected units were to be replaced with new firmware and new digital motion control boards.All other documentation for the dx-d100 reportable correction will be reported via (b)(4).
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