The U.S. Food and Drug Administration (FDA) has filed an adverse event report for a North Carolina mammography facility.
In October of last year, the FDA initiated an additional review of mammograms performed at SonoCare of Morganton due to deficiencies noted during an August Mammography Quality Standards Act (MQSA) inspection. In December, the American College of Radiology (ACR) notified the FDA and the facility that the review showed serious clinical image quality deficiencies; later that month, the ACR revoked SonoCare's mammography accreditation.
The FDA required SonoCare to alert its patients and their providers of the image quality problems, which the facility did in April. However, SonoCare is currently not performing mammography, the FDA said.
