News | April 02, 2015

FDA Issues Alert on Mammography Quality Problems at North Carolina Facility

Patients advised to have their mammograms reviewed for any needed follow-up

FDA, Richard D. Adelman M.D. Family Medicine, mammogram quality, problems

April 2, 2015 — The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine in Raleigh, North Carolina, about possible problems with the quality of their mammograms. The alert applies to patients who had mammograms any time after Aug. 24, 2012.

The American College of Radiology (ACR) did a review of mammograms performed by the practice between Aug. 25, 2012, and Aug. 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility’s accreditation on Nov. 5, 2014. On Nov. 18, the FDA required the facility to notify all patients who received mammograms at its facility any time after Aug. 24, 2012, about these problems, and to stop performing mammography.

This does not necessarily mean that the results of the mammograms were inaccurate, but patients should have their mammograms reviewed at a Mammography Quality Standards Act (MQSA)-certified facility to determine if they need a repeat mammogram or additional medical follow-up. Patients have the right to request their original mammogram and copies of their medical reports from Richard D. Adelman, M.D., Family Medicine practice. 

For more information:

Related Content

Microbubbles Make Breast Cancer More Susceptible to Radiation Therapy
News | Women's Health | February 01, 2018
February 1, 2018 – Injecting breast cancer with oxygen-filled microbubbles makes tumors three-times more sensitive to
An example of opto-acoustic breast imaging using the Seno system.

An example of opto-acoustic breast imaging using the Seno system.  

Feature | RSNA 2017 | January 29, 2018
January 26, 2017 — There were three high-impact clinical trials presented at the 2017 Radiological Society of North A
What It Takes to Remain an MQSA-Qualified Inspector
Feature | Mammography | January 26, 2018
The U.S. Food and Drug Administration (FDA) published a new Insight Article detailing the oversight process for the...
Transpara Deep Learning Software Matches Experienced Radiologists in Mammogram Reading
News | Computer-Aided Detection Software | January 12, 2018
Deep learning and artificial intelligence improves the efficiency and accuracy of reading mammograms, according to...
Fat Distribution in Women and Men Provides Clues to Heart Attack Risk
News | Women's Health | January 11, 2018
January 11, 2018 – It’s not the amount of fat in your body but where it is stored that may increase your risk for hea
Women Prefer Getting Mammograms Every Year
News | Mammography | January 09, 2018
Women prefer to get their mammograms every year, instead of every two years, according to a new study presented at the...
Planmed Clarity 2-D Digital Mammography System Receives FDA Approval
Technology | Mammography | January 08, 2018
The U.S. Food and Drug Administration (FDA) issued an approval letter for the Planmed Clarity 2-D full-field digital...
Overweight Women May Need More Frequent Mammograms
News | Mammography | January 04, 2018
Women with higher body mass index (BMI) face an increased risk of not detecting their breast tumor until it has become...
Overlay Init