Mammography Facility Adverse Event and Action Report – May 08, 2018: SonoCare, LLC

Mammography Facility Adverse Event and Action Report – May 08, 2018: SonoCare, LLC

On October 24, 2017, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to deficiencies noted during the August 22, 2017 MQSA Inspection performed jointly by the State of North Carolina and the FDA. On December 13, 2017, the ACR notified the FDA and the facility that the AMR revealed serious deficiencies with clinical image quality and failed to meet the ACR’s clinical image evaluation criteria.Continue reading.