Inspection report failed.Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2.On (b)(6): inspection report failed.Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2.Then on (b)(6) confirmation of the issue: fse diagnosis & work performed: check system according checklist #(b)(4) found maximum fluoroscopic at 11.3 r/min, adjusted to 9.7 for adult and pediatric at 4.2 and removed a piece of metal between table top and image intensifier witch is blocking the image and check collimator blades all normal.The problem was corrected (as explained above) and that the suspected root cause at this time would be : a miscalibration of the device upon servicing resulting in the maximum output of the system is set to 11.3 r/min while it should not exceed 10r per minute in fluoro.The setting works when the system is in the automatic mode.This may have resulted in the remote possibility of reaching this maximum output in case a very overweight person had undergone a procedure with this setting.To be noted that the device does not have high level fluoro.
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