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  1. Facility Certification and Inspection (MQSA)

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

Title Date
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication 05/21/2021
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication 03/30/2021
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication 05/20/2020
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication 09/25/2020
Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication [ARCHIVED] 04/26/2019
Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety Communication [ARCHIVED] 09/24/2018
Problem with Quality of Mammograms at Palm Beach Broward Medical Imaging Center in Deerfield Beach, Florida: FDA Safety Communication [ARCHIVED] 01/03/2018
Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication [ARCHIVED] 08/17/2015
Problem with Quality of Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication [ARCHIVED] 04/30/2015
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] 04/13/2015
Problems with Quality of Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication [ARCHIVED] 03/24/2015
Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication [ARCHIVED] 06/23/2014
Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico: FDA Safety Communication [ARCHIVED] 06/27/2013
Medisound, Inc./Digital Radiology Center, in Kissimmee, Florida Performing Mammography Without an MQSA Certificate: FDA Safety Communication [ARCHIVED] 09/28/2012
Mammography Problems at Huntington Radiology in Huntington Park, California [ARCHIVED] 03/10/2011

 

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