MQSA Reports and Safety Notifications

Reports to Congress

• 2018 MQSA Report to Congress on Performance of Accreditation Bodieshyperlink inserted

Mammography Facilities with Revoked MQSA Certificates

• Mammography Facilities with Revoked MQSA Certificate (Advanced Women Imaging 02-07-23)
• Mammography Facilities with Revoked MQSA Certificate (Capitol Radiology, LLC 06-30-22)

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Safety Notifications

Under the Mammography Quality Standards Act (MQSA), 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 the FDA's satisfaction that all affected patients were successfully notified, the FDA posts Mammography Safety Notifications to this website.

Title	Date
Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication	02/07/2023
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication	08/26/2021
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication	05/20/2021
Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication	03/30/2021
Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication [ARCHIVED]	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:06/23/2014 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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Mammography Facility Adverse Event and Action Reports

The MQSA requires these reports be made available to physicians and the general public [see 42 USC 263b(l)(1)]

2024

• Mammography Facility Adverse Event and Action Report – March 5, 2024: Desert Imaging Services L.P.
• Mammography Facility Adverse Event and Action Report – March 5, 2024: Stockdale Radiology
• Mammography Facility Adverse Event and Action Report – March 5, 2024: Farmbrook Radiology

The most recent Mammography Facility Adverse Event and Action Reports are listed by year. Older Mammography Facility Adverse Event and Action Reports are denoted by (Archive).

• 2023 Mammography Facility Adverse Event and Action Reports
• 2022 Mammography Facility Adverse Event and Action Reports
• 2021 Mammography Facility Adverse Event and Action Reports
• 2020 Mammography Facility Adverse Event and Action Reports (Archived)
• 2019 Mammography Facility Adverse Event and Action Reports (Archived)
• 2018 Mammography Facility Adverse Event and Action Reports (Archived)
• 2017 Mammography Facility Adverse Event and Action Reports (Archived)
• 2016 Mammography Facility Adverse Event and Action Reports (Archived)
• 2015 Mammography Facility Adverse Event and Action Reports (Archived)

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Document Archives (MQSA)

• Archived Documents - Not for Official Use