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 10th event in which a customer engineer informed agfa on (b)(4) 2013, that he had performed the dx-d100 latest version upgrade of the firmware, per a mandatory service bulletin by agfa, and checked the gauges, voltage and encoder connections.The unit worked perfectly the first day, but within a few days the unit exhibited erratic movement.As this unit was installed nearly two months prior to this event, the unit was pulled from use and a backup system used by the site.Agfa determined there was a defective part for the digital motion control board; therefore, after working with sedecal, the vendor supplying the replacement parts, agfa replaced the digital motion control board, gauges and adjusted voltages with good parts.The dx-d100 unit for this site is now working as expected.No harm has been reported for this event.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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