Int.Ref.(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 stitching patient support.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.Philips field service engineer visited the customer site and confirmed there were no parts damaged.Due to loose screws the lower part of the brake cylinder was just detached from the base frame.Philips field service engineer reinstalled the screws tightly and checked the system.System works as specified.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.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.
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