FDA alerts patients after multiple complaints at West Coast imaging center

The U.S. Food and Drug Administration alerted patients on Friday about poor care quality at a West Coast imaging center, warning individuals they may need to be re-imaged. 

Concerns stem from scans provided at the Mammography Center of Monterey, on the central coast of California. Regulators received multiple complaints from patients examined at the facility, according to an FDA alert dated Aug. 28. 

Purportedly, the center failed to provide mammography reports to providers and written lay summaries to patients within 30 days of examinations. Complaints also charge that the center did not transfer records within 15 days of request. 

The Mammography Center of Monterey also botched an imaging review ordered by the American College of Radiology in June and has been barred from providing breast imaging.

“Some clinical image quality deficiencies were severe,” the Food and Drug Administration said in its notice, adding that the center is now required to submit an “extensive corrective action plan to the ACR.” 

The phone number listed on MCM’s website was not in service as of Friday. Multiple one-star patient reviews on Yelp report problems with reaching the center and receiving results. Others claim that they had an appointment at the facility but showed up to find the doors locked. 

“I waited 6 weeks for my results. Inexcusable, especially since the ultrasound technician focused on getting many pictures of a certain spot. This seems unprofessional to say the least,” Yelp user Terry D., of Pacific Grove, California, wrote in October.

“At my last visit, in October 2025, the radiology technician was different, and I received the poorest tech assistance I'd ever experienced,” Kate D., of Carmel Valley, California, wrote in an April post. “The lack of accurate positioning for my mammogram and DEXA scan was shocking. The results were never sent to my referring doctor. Now I am paying out of pocket for a second DEXA.”

The FDA is alerting anyone who received mammograms at the center on or after Dec. 22, 2023. Those who visited MCM before then are urged to consider asking for their mammograms and copies of their medical reports. The FDA is urging these individuals to have their information reviewed by another certified facility to decide if repeat imaging or further follow-up is needed. 

MCM also failed to adequately respond to multiple notifications from the ACR regarding these concerns. On Dec. 10, the college notified the facility of its intent to review its accreditation. MCM did not appeal and saw its credentials revoked in December. 

The FDA later required the center to notify at-risk patients on June 22, and as of Friday, it had not complied with the Patient and Provider Notification order. MCM may not legally perform mammography until further notice, with no active certificate. 

“The FDA will continue to monitor this issue and keep the public informed as new information becomes available,” the notice reads. “At this time, the FDA recommends that patients contact Mammography Center of Monterey to gain access to their medical records.”