Medical Device Safety: Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA Safety Communication

A safety communication has been issued due to a problem with the quality of mammograms at Boston Diagnostic Imaging in Orlando, Florida.

The FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up. Patients have the right to request their mammogram and copies of their medical reports from Boston Diagnostic Imaging.

For more information, please see:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm458643.htm.