The U.S. Food and Drug Administration (FDA) has posted a warning regarding serious image quality deficiencies at a mammography center in West Palm Beach, Florida.
An inspector first noted quality control deficiencies for mammograms performed at the Breast Institute at JFK Medical Center North Campus in June 2019. Following the inspection, the FDA requested the American College of Radiology (ACR) perform an additional review of the facility.
The ACR notified the FDA in October 2019 that JFK Medical Center's breast screening center had serious clinical image quality deficiencies. The ACR then revoked the center's mammography accreditation, and the FDA suspended the facility's Mammogram Quality Standards Act (MQSA) certificate.
As of February 13, the Breast Institute at JFK Medical Center North Campus had notified patients and providers about the image quality problems. The center is currently not performing mammography and has not applied for mammography accreditation.
