News | Mammography | March 30, 2016

FDA Revokes MQSA Certificate of California Mammography Facility

Facility was subject of previous FDA Safety Notification on poor mammogram quality; patients who received mammograms on or after Sept. 8, 2014, advised to have results re-evaluated elsewhere

FDA alert, Huntington Radiology, California, MQSA certificate revoked

March 30, 2016 — The U.S. Food and Drug Administration (FDA) revoked the Mammography Quality Standards Act (MQSA) certificate of J. Bruce Jacobs M.D. Inc., doing business as Huntington Radiology in Huntington Park, Calif., on March 4. The FDA is alerting patients who had mammograms at the facility any time on or after Sept. 8, 2014, about possible problems with the quality of their mammograms.

This facility was the subject of a prior FDA Safety Notification issued on March 10, 2011.

The American College of Radiology (ACR) conducted a review of mammograms performed at the facility between Sept. 8, 2014, and Nov. 4, 2014. The clinical image review was conducted for the purposes of accreditation reinstatement following the Aug. 31, 2010, ACR revocation of the facility’s accreditation. On Sept. 8, 2014, the facility was provisionally certified to provide mammography services; however, a subsequent ACR clinical image review indicated problems with the quality of the mammography at the facility. The ACR revoked the facility's application for accreditation effective Feb. 20, 2015, and the FDA suspended the facility’s certificate on March 6, 2015.

On April 8, 2015, the FDA required the facility to notify all patients who received mammograms at its facility any time on or after Sept. 8, 2014, and their referring healthcare providers, about the problems with the mammography quality at the facility.

In accordance with its rules and requirements the State of California, Health and Human Services Agency, California Department of Public Health issued a Cease and Desist Order against the facility on Feb. 9, 2015, based on a state investigation and the findings noted by the ACR during the Additional Mammography Review (AMR).

Under the MQSA of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet standards for mammography quality under the Act. The facility may not legally perform mammography at this time due to the suspension of its certificate.

This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at an MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.

The FDA will continue to monitor this issue and keep the public informed as new information becomes available.

For more information:

Related Content

Joseph J. Cappello Named Executive Director of Are You Dense Nonprofits
News | Breast Density | February 20, 2019
The boards of Are You Dense Inc. and Are You Dense Advocacy Inc., founded by the late Nancy M. Cappello, Ph.D.,...
Congress Directs FDA to Establish Federal Breast Density Inform Standard
News | Breast Density | February 19, 2019 | Jeff Zagoudis, Associate Editor
As part of a federal spending bill passed late Friday, Congress directed the U.S. Food and Drug Administration (FDA) to...
Densitas Enters Partnership Agreement With TeleMammography Specialists
News | Breast Density | February 14, 2019
Breast imaging analytics company Densitas Inc. announced a new collaboration partnership with TeleMammography...
Hologic Launches Unifi Analytics Business Intelligence Tool
Technology | Analytics Software | February 12, 2019
Hologic Inc. announced the U.S. launch of Unifi Analytics, a business intelligence tool that allows healthcare...
Mount Sinai's Digital 3-D Mammography Van Rolls Into New York City
News | Mammography | February 11, 2019
Mount Sinai Hospital recently launched the Mount Sinai Mobile Mammography Program (MMP), bringing essential breast...
breast density cancer awareness
News | Breast Density | February 08, 2019
Governor Michelle Lujan Grisham has signed breast density inform bill, ...
Fujifilm Launches Latest Synapse 3D Version at HIMSS 2019

The new Intravoxel Incoherent Motion (IVIM) MR application in Synapse 3D

Technology | Advanced Visualization | February 08, 2019
Fujifilm Medical Systems U.S.A. will debut the latest version of its Synapse 3D solution at the Healthcare Information...
Siemens Healthineers Syngo.Breast Care Adding AI-Based Decision Support
News | Clinical Decision Support | February 05, 2019
Siemens Healthineers showcased the new planned artificial intelligence (AI)-based features with its mammography reading...
 Volpara Solutions Launches Next-Generation VolparaDensity Software to Support SmartCurve Paddles
Technology | Breast Density | January 31, 2019
Volpara Solutions Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for new technologies used in...
QTbreasthealth Opens New Breast Ultrasound Imaging Center in Grand Rapids
News | Ultrasound Women's Health | January 30, 2019
January 30, 2019 — QTbreasthealth launched a center in Grand Rapids, Mich., featuring its quantitative transmission