According to an untitled letter, FDA Sept. 27 conducted field tests of two certified diagnostic x-ray systems at the facility of GE Medical Systems to determine its compliance with portions of the Performance Standard for Diagnostic X-Ray Equipment.

During testing on both systems, X-ray production was possible when the primary protective barrier was not in position to intercept the X-ray beam as required by FDA regulation.

FDA requested the company investigate the deviation from the performance standard and/or the defect listed above in accordance with regulation as ...

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