FDA issues mammography alert for Tenn. facility

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The U.S. Food and Drug Administration (FDA) said it's alerting patients who received mammograms at Tennessee Women's Care in Nashville, TN, on or after November 1, 2019, that there may be possible problems with the quality of their mammograms.

The FDA had notified the facility that it was required to undergo an annual mammography review (AMR) after the practice's annual Mammography Quality Standards Act (MQSA) inspection indicated that required quality control tests were not performed from November 1, 2019, through August 17, 2020. However, the facility did not respond to a request by the American College of Radiology (ACR) for clinical images and documentation needed to conduct the AMR, the FDA said.

As a result, the ACR revoked the facility's accreditation on December 28, 2020, and the FDA placed the facility's MQSA certificate in a "no longer in effect" status. Consequently, the facility may not legally perform mammography at this time, according to the FDA.

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