Ref.Id: (b)(4).The digitaldiagnost c90 highperformance is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.The local field service engineer (fse) went on site, checked the detector and tried several times to connect to the system with no success.He collected logs and other information to sent for analysis to get the detector replaced.Fse installed the new detector.Finally, the system meets the specification for the performed service and is returned to use.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).Risk estimation revealed acceptable risk per risk benefit analysis, because actually, there is no feasible technical solution for this kind of ¿use error¿.This issue is further monitored and trended.Correction: h6 result and conclusion.
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