Radiation-Emitting Products

Mammography Safety Notifications

Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards. When a facility fails to meet the standards, the FDA requires it to notify affected patients and their referring health care providers that their recent mammograms could have unreliable results.

In the cases where a facility cannot or will not demonstrate to FDA's satisfaction that all affected patients were successfully notified, the FDA posts Mammography Safety Notifications to this website. 

Safety Notifications

Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication [ARCHIVED] 08/17/15
Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication [ARCHIVED] 04/30/15
Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology in Huntington Park, California: FDA Safety Notification [ARCHIVED] 04/13/15
Problems with Quality of Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication [ARCHIVED] 03/24/15
Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication [ARCHIVED] 06/23/14
Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico [ARCHIVED] 06/27/13
Medisound, Inc./Digital Radiology Center, in Kissimmee, Florida Performing Mammography Without an MQSA Certificate [ARCHIVED] 09/28/12
Mammography Problems at Huntington Radiology in Huntington Park, California 03/10/11
Mammography Problems at Med Pro Imaging in Plantation, Florida [ARCHIVED] 08/17/10
Mammography Problems at Medisound, Inc. in Kissimmee, Florida [ARCHIVED] 08/27/10

Page Last Updated: 02/26/2016
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