News | March 11, 2011

FDA Issues Safety Notification for California Imaging Center

March 11, 2011 - The U.S. Food and Drug Administration (FDA) is alerting referring physicians of poor quality reads on mammography exams at Huntington Radiology in Huntington Park, Calif.

The FDA said the safety notification concerns patients who had a mammogram at Huntington Radiology between Sept. 9, 2008, and Sept. 9, 2010. The FDA said it became aware of problems associated with the quality of mammograms performed at the facility. The FDA worked with the American College of Radiology (ACR) to perform a review of a sample of mammograms performed by Huntington Radiology that included images taken between Sept. 9, 2008, and Sept. 9, 2010. Results from that review included poor-quality mammograms with possibly unreliable results.

Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high-quality standards. This facility did not meet standards for mammography quality under that Act. The facility has not performed mammography exams since Sept. 9, 2010, because ACR revoked its accreditation and its MQSA certificate is no longer in effect.

Although Huntington Radiology has sent letters to patients and their referring healthcare providers, it has been unable to demonstrate to FDA’s satisfaction that all affected patients were successfully notified. The FDA said it is alerting patients who had mammograms at this facility between the dates in question. The agency said this does not mean that the results of all of the examinations were inaccurate, but patients might need to have their mammograms re-evaluated and possibly repeated.

For more information: [email protected]

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