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.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.The mounting of the lower part of the brake cylinder was just detached from the base frame, the probable cause could not be determined.The injury to the tech was not confirmed.The field service engineer corrected the issue by refixing the foot board mounting plate with the brake cylinders and checked the system.System works as specified.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.
|