Mammography Update: Mammography Facility Adverse Event and Action Report - August 5, 2015: Coastal Diagnostic Center

A Mammography Facility Adverse Event and Action Report has been posted regarding Coastal Diagnostic Center of Pismo Beach, California.  On February 24, 2015, the American College of Radiology (ACR) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to serious image quality problems identified during the review of clinical images submitted for accreditation renewal. On March 31, 2015, the ACR notified the facility that mammograms reviewed during the AMR did not meet the ACR’s criteria for clinical image quality and that the deficiencies posed a serious risk to human health.

To read the action taken, corrective action, and status of the facility, please see: http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Reports/ucm457407.htm