Ref.Id: (b)(4).The combidiagnost is a remote controlled system, which supports general radiography and fluoroscopy imaging.Philips field service engineer investigated on site.He replaced the defective skyplate with new one and performed gain and pixel calibration.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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