News | Mammography | March 30, 2016

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: www.fda.gov


Additional Content

News | Women's Health

Oct. 29, 2026 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive ...

Time October 30, 2026
arrow
News | Radiopharmaceuticals and Tracers

Oct. 19, 2026 — Nuclidium AG, a clinical-stage radiopharmaceutical company, and NorthStar Medical Technologies, a global ...

Time October 19, 2026
arrow
News | Women's Health

Oct. 15, 2026— SimBioSys has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of TumorSight Risk, its ...

Time October 19, 2026
arrow
News | Breast Imaging

Oct. 6, 2026 — The American College of Radiology (ACR) has recognized Mercy Medical Center’s Tyanna O’Brien Center for ...

Time October 09, 2026
arrow
News | Ultrasound Women's Health

Sept. 29, 2026 — A research team at the University of Virginia (UVA) led by Timothy Bullock, PhD, has published results ...

Time September 30, 2026
arrow
Subscribe Now