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not performed mammography exams since Sept. 9, 2010, because ACR revoked its accreditation and its MQSA certificate is no longer in effect.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: MQSAhotline@hcmsllc.com


Related Content

News | Digital Radiography (DR)

July 10, 2025 — Fujifilm Healthcare Americas Corp. has launched several advanced automated functions for its FDR ...

Time July 10, 2025
arrow
News | Breast Imaging

July 8, 2025 — QT Imaging Holdings, has appointed Elaine Iuanow, MD, as chief medical officer (CMO) and Kim Du as senior ...

Time July 09, 2025
arrow
News | Breast Imaging

July 7, 2025 — SimonMed Imaging, one of the largest outpatient medical imaging providers in the United States, has ...

Time July 08, 2025
arrow
News | Computed Tomography (CT)

July 01, 2025 — NANO-X Imaging Ltd. recently announced a clinical and educational collaboration with Keiser University ...

Time July 03, 2025
arrow
News | Ultrasound Imaging

June 26, 2025 — FUJIFILM VisualSonics Inc., a provider of ultra-high frequency ultrasound and photoacoustic imaging ...

Time June 27, 2025
arrow
News | Breast Imaging

June 25, 2025 — QT Imaging Holdings, Inc., a medical device company engaged in research, development, and ...

Time June 25, 2025
arrow
News | Imaging Software Development

June 12, 2025 — GE HealthCare has announced the combination of GE HealthCare’s proprietary features and algorithms with ...

Time June 12, 2025
arrow
News | Radiology Business

The issue of sustainability in healthcare has gained increasing focus over the past several years. During a 2022 plenary ...

Time May 06, 2025
arrow
News | Mammography

April 29, 2025 — iCAD, a global provider of clinically proven AI-powered cancer detection solutions, has announced a ...

Time April 29, 2025
arrow
News | Mammography

April 24, 2025 — GE HealthCare will feature its latest advancements in diagnostic accuracy and patient-centered breast ...

Time April 24, 2025
arrow
Subscribe Now