(b)(4).The digitaldiagnost is a direct digital radiography x ray system with flat detector technology based on modular components to allow for customization for all radiographic applications and workload requirements.The patient support for stitching is an accessory that enables the examination of full leg or full spine, with the patient standing upright.For easy use, the patient support for stitching has wheels and a folding footboard.The investigation showed that the customer patient support for stitching is not compatible with the field corrective action.Therefore it was decided to exchange the complete patient support for stitching against a new type of patient support for stitching, where all updates are already implemented in the new design.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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