FDA MedWatch - FDA Safety Communication

Mammography Problems at Tennessee Women's Care

MedWatch - The FDA Safety Information and Adverse Event Reporting Program Mammography Problems at Tennessee Women's Care P.C. - FDA Safety Communication The FDA is alerting patients who had mammograms at Tennessee Women's Care P.C., located in Nashville, TN, on or after November 1, 2019, about possible problems with the quality of their mammograms. Health care providers and patients should consider having these mammograms re-evaluated at a Mammography Quality Standards Act-certified facility to determine if a repeat mammogram or additional medical follow-up is needed. The Tennessee Women's Care P.C. may not legally perform mammography at this time. This safety communication provides: A summary of the problems with the quality of mammography performed at Tennessee Women's Care P.C. Information and recommendations for patients who had a mammogram at Tennessee Women's Care P.C. any time on or after November 1, 2019 Questions? If you have questions about this issue, contact the Mammography Quality Standards Act Hotline by phone at 1-800-838-7715, email at MQSAhotline@versatechinc.com, or fax at 1-443-285-0689.

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