Ref.Id: (b)(4).The digitaldiagnost c90 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.Philips field service engineer investigated on site and performed a pixel and gain calibration of the affected detector, but without success.The detector needs to be replaced.A quote for the exchange of the defect detector was sent to the customer, but they did not order it until it had expired.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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