Ref.Id: (b)(4).The digitaldiagnost 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 affected detector.The detector needs to be replaced.After replacement and configuration of skyplate detector was done, the system meets the specification for the performed service and is returned to use.The detector was dropped by user.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.
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