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U.S. Department of Health and Human Services

Radiation-Emitting Products

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How is a "serious complaint" defined?

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A serious complaint is defined as a report of a serious adverse event, which means an event that significantly compromises clinical outcomes or one for which a facility fails to take appropriate corrective action in a timely manner. Examples of serious adverse events include: poor image quality, missed cancers, the use of personnel that do not meet the applicable requirements of 900.12 (a), and failure to send to the appropriate person(s) mammography reports or lay summaries within 30 days.

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