Ref.Id: (b)(4).The combidiagnost r90 is a remote controlled multi-functional general r/f system.It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.Fluoroscopy exam images are reviewed via the rf viewer.First investigation by dxr application specialist confirmed that the issue could be reproduced, one dx image was displayed on the rf viewer for a different patient exam.It can happen if images are being exported whilst at the same time a fluoroscopy examination is in progress.Investigation by development dxr determined that the issue is caused by a defect in the application software.A capa investigation leads to a field safety corrective action fco70900057.The system has been removed from this hospital, therefore no correction are possible for this site.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.Correction: h6 result and conclusion.
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