Ref.Id: (b)(4).The digitaldiagnost is a direct digital radiography system with flat detector technology based on modular components to allow customization for all radiographic applications and workload requirements.For anatomies that are larger than the detector size like scoliosis, it is possible to make a series of exposures covering the whole anatomy (for example full spine or full legs).These individual images can be "stitched" together via the software program.For proper patient positioning and support, the patient can be placed on the so called patient support for stitching or stitching stand, a platform with two handles that the patient can hold on to during the examination.For the ease of use during transportation, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a brake cylinder.It has to be folded up and fixed by a hook for transportation, e.G.From one room to another.Philips field service engineer visited the customer site.The mounting of brake cylinder was detached and cannot be fixed on the frame, the intended position has been deformed.Hence field service engineer reinstalled the screws tightly and checked the system.System works as specified.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.
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