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 17th event in which an agfa field service engineer informed agfa on (b)(6) 2013, that a customer stated their dx-d100 unit was showing signs of unintended movement.The engineer 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 did not respond well to the upgrade.Agfa is currently awaiting parts to repair the unit and confirm mandatory service has been performed correctly per the reportable correction reported to the fda on may 15, 2013: fda reference # (b)(4).No harm has been reported for this event.Agfa investigation was already underway for a reportable correction to the fda on may 15, 2013: fda reference # (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 fda (b)(4).
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