Ref.Id: (b)(4).The digitaldiagnost 3.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "wpd", wireless portable detector) can be used for image capture.Philips field service engineer investigated on site.He performed function test and detector calibration which eliminated the artifacts.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.
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