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  1. MQSA Reports and Safety Notifications

Mammography Problems at Mammography Center of Monterey in Monterey, California: FDA Safety Notification

Date Issued: August 28, 2026

The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Mammography Center of Monterey, located in Monterey, California, on or after December 22, 2023, about possible problems with the quality of their mammograms.

Recommendations for Patients

  • If you have had a more recent mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after December 22, 2023, follow the recommendations from that facility.
  • If you have not had a mammogram at a different Mammography Quality Standards Act (MQSA)-certified facility on or after December 22, 2023, follow these guidelines:
    • Consider asking for your mammogram and copies of your medical reports from Mammography Center of Monterey, and have your mammogram reviewed at another MQSA-certified facility to decide if a repeat mammogram or more medical follow-up is needed. As a patient, you or your representatives have the right to ask for your mammograms and copies of your medical reports.  
    • A database of Mammography Quality Standards Act (MQSA)-certified facilities can be found online, or you can call the National Cancer Institute's information telephone number at 1-800-422-6237 to find a MQSA-certified facility in your area.

Device Description

A mammogram is a safe, low-dose, X-ray picture of the breast. It is currently the most effective primary screening method for detecting breast cancer in its earliest, most treatable stages.

Summary of Problem or Scope

The FDA became aware of problems associated with the quality of mammograms performed at:

Mammography Center of Monterey
798 Cass St Ste 205
Monterey, CA 93940

Mammography Center of Monterey's accreditation body, the American College of Radiology (ACR) and FDA received multiple consumer complaints alleging that the facility failed to provide written mammography reports to healthcare providers and written lay summaries to patients within 30 days of mammographic examinations performed at the facility.  Complaints also alleged that the facility failed to transfer mammography records within 15 days of request.  Based on this information, on October 31, 2025, ACR notified the facility to submit a letter of corrective action.

The facility failed to respond adequately to multiple notifications from the ACR regarding these concerns.  On December 10, 2025, the ACR notified the facility of its intent to revoke the facility's accreditation. The ACR provided the facility with an opportunity to appeal the proposed revocation by December 15, 2025. Mammography Center of Monterey did not submit an appeal, and on December 17, 2025, the ACR revoked the facility's accreditation.

The FDA inspected the facility on December 16, 2025. The inspection confirmed that the facility failed to communicate mammography results to some patients and healthcare providers within 30 calendar days of mammographic examinations performed at the facility. On December 22, 2025, the FDA placed Mammography Center of Monterey's MQSA certificate into a “no longer in effect” status. This facility may not legally perform mammography at this time, as it does not have an active MQSA certificate. Based on the results of the for-cause inspection, FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR), performed by the ACR, to determine whether the overall quality of mammography performed at the facility had been compromised by its failure to operate in compliance with the MQSA, and whether affected patients should be notified.

On June 11, 2026, the ACR issued the AMR report to the facility. The facility failed the AMR. Some clinical image quality deficiencies were severe. The facility is required to submit an extensive corrective action plan to the ACR.

On June 22, 2026, the FDA required Mammography Center of Monterey to notify at-risk patients who had mammography examinations performed at the facility on or after December 22, 2023, and their referring healthcare providers, about possible problems with the quality of their mammograms. As of the posting of this Safety Notification, the facility has not complied with the FDA’s Patient and Provider Notification (PPN) order.

Under the MQSA, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. Mammography Center of Monterey did not meet the standards for mammography quality under the MQSA. This facility may not legally perform mammography at this time. The facility is not currently accredited and does not have an active MQSA certificate.

FDA Activities

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

Contact Information

If you have questions about this notification, please contact the Mammography Quality Standards Act Hotline by phone: 1-800-838-7715, email: MQSAhotline@versatechinc.com or fax: 1-443-285-0689.

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