The FDA has alerted patients who had mammograms at Mammography Center of Monterey (Calif.) on or after Dec. 22, 2023, to possible quality problems with their mammograms.
The facility failed an additional mammography review, with some deficiencies in clinical image quality deemed severe, according to an Aug. 28 FDA safety notification. The FDA ordered the facility on June 22, 2026, to notify at-risk patients and their referring healthcare providers. As of the safety notification, the facility had not complied with the order.
The American College of Radiology revoked the facility’s accreditation on Dec. 17, 2025. Five days later, the FDA placed its Mammography Quality Standards Act certificate into “no longer in effect” status.
The facility cannot legally perform mammograms and is not accredited or operating with an active Mammography Quality Standards Act certificate.
The FDA recommends affected patients who have not received a more recent mammogram at another certified facility consider obtaining their records and having their mammograms reviewed at another certified facility.
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