This medical 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 4th event in which agfa was notified by the site on (b)(6) 2013, that they had experienced their dx-d100 unit exhibiting irregular movements, turning to the right or moving forward or backwards with no command and colliding with a door.There was no reported harm for this instance.Agfa made adjustments to the voltage on the digital motion control board for the gauges and replaced additional parts and the unit worked well and drove smoothly.Agfa investigation led to a reportable correction to the fda on may 15, 2013, : (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.The dx-d100 unit for this site is now working as expected.All other documentation for the dx-d100 reportable correction will be reported via (b)(4).
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