Ref.Id: (b)(4).The digitaldiagnost r3.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "wpd") can be used for image capture.Philips field service engineer (fse) investigated on site and confirmed the reported issue.Artefacts are visible.He checked the detector and tried several times to calibrate with no success.A quote has been sent to customer to replace the affected detector.The customer rejected the replacement, because they plan to replace the entire system very soon.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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