The U.S. Food and Drug Administration is advising patients who received mammograms at Mammography Center of Monterey in California on or after December 22, 2023 to consider whether their images should be reviewed by another certified mammography facility. The August 28 safety notification followed a regulatory investigation in which the facility failed an Additional Mammography Review and some clinical image-quality deficiencies were found to be severe.
The FDA emphasized that patients who have since received another mammogram at a different Mammography Quality Standards Act-certified facility on or after December 22, 2023 should follow the recommendations from that newer facility. Patients without a subsequent certified mammogram are being advised to consider obtaining their previous images and medical reports and having them evaluated by another MQSA-certified facility to determine whether repeat imaging or further medical follow-up is appropriate.
Who is affected by the FDA Mammography Center of Monterey warning?
The notification applies specifically to patients whose mammography examinations were performed at Mammography Center of Monterey, located in Monterey, California, on or after December 22, 2023.
The FDA has not said that every mammogram performed during that period was inaccurate.
The issue is that regulators found sufficient concerns about overall quality that patients cannot automatically assume every affected examination met required standards.
That is an important distinction because broad safety warnings can cause unnecessary panic. The recommendation is not that every patient immediately undergo another mammogram regardless of circumstances. It is to have the previous examination reviewed at a certified facility when there has not already been a newer qualified mammogram.
What did regulators find wrong at the Monterey mammography center?
The regulatory history involves more than image quality alone.
The American College of Radiology and the FDA received multiple consumer complaints alleging that the center had failed to provide written mammography reports to healthcare providers and lay summaries to patients within the required 30-day period. Complaints also alleged delays in transferring mammography records after patients requested them.
The American College of Radiology asked the facility to submit corrective action, later notified it of an intention to revoke accreditation and ultimately revoked the accreditation on December 17, 2025 after the facility did not appeal. An FDA inspection conducted the previous day confirmed failures to communicate some mammography results within the required timeframe.
On December 22, 2025, the FDA placed the facility’s MQSA certificate into “no longer in effect” status.
The facility was then required to undergo an Additional Mammography Review conducted by the American College of Radiology to determine whether noncompliance had compromised overall mammography quality.
How serious were the mammogram image-quality problems?
Serious enough that the facility failed the additional review.
The American College of Radiology issued its Additional Mammography Review report on June 11, 2026. According to the FDA, some clinical image-quality deficiencies were severe, and the facility was required to submit an extensive corrective-action plan.
The FDA subsequently ordered the center on June 22 to notify at-risk patients who had undergone mammography since December 22, 2023, along with their referring healthcare providers.
As of the August 28 public safety notification, the FDA said the facility had not complied with that patient-and-provider notification order.
That lack of compliance explains why the agency itself is now publicly alerting potentially affected patients.
Why does mammogram image quality matter so much?
Mammography is intended to find breast cancers when they may still be small and more treatable.
Producing a diagnostic-quality mammogram requires far more than simply exposing the breast to X-rays. Correct positioning, compression, exposure, equipment calibration, image contrast and other technical factors all determine whether the radiologist can adequately evaluate the tissue.
Poor positioning can leave relevant tissue outside the image. Technical problems can obscure subtle calcifications, masses or architectural distortion.
The consequences can move in both directions. Poor-quality imaging can potentially contribute to missed abnormalities, while ambiguous images can also cause unnecessary follow-up testing.
That is why the Mammography Quality Standards Act establishes federal requirements around equipment, personnel, quality assurance, image review and recordkeeping.
Is Mammography Center of Monterey still allowed to perform mammograms?
No, according to the FDA’s August 28 notice.
The agency says the facility is not currently accredited, does not have an active MQSA certificate and may not legally perform mammography at this time.
Federal law requires qualifying U.S. mammography facilities to maintain MQSA certification and accreditation.
The rules exist because breast-cancer screening depends on consistency across thousands of facilities. A patient should not need to be an imaging expert to determine whether the machine, technologist and interpreting physician meet basic federal quality standards.
What should someone do if they had a mammogram there?
The FDA divides affected patients into two practical groups.
Patients who already had a more recent mammogram at another MQSA-certified facility on or after December 22, 2023 should follow the recommendations from that newer facility.
Those who have not had a newer certified mammogram should consider obtaining copies of their previous mammograms and medical reports from Mammography Center of Monterey. The FDA recommends having those images reviewed by another MQSA-certified facility to determine whether another mammogram or additional follow-up is appropriate.
The agency is not telling patients to diagnose image quality themselves.
A qualified facility can examine the prior study within the context of the patient’s age, breast density, previous findings and screening history.
Does a poor-quality mammogram mean breast cancer was missed?
Not necessarily.
A quality deficiency increases uncertainty; it does not establish that a particular patient had a cancer that went undetected.
Many affected patients may ultimately learn that their previous imaging was adequate or that newer screening has already resolved the concern.
The reason for review is precisely that the answer cannot safely be assumed.
Patients should therefore avoid interpreting the FDA warning as evidence that they have cancer or that every examination at the facility was unreliable.
Why could this FDA warning become an important patient-search story?
Unlike many device regulatory actions, the Monterey notification creates a direct question for a defined group of patients: “Was my mammogram one of the affected examinations, and what should I do?”
That produces exceptionally high-intent search behavior.
The story also highlights a broader weakness in screening systems. Breast-cancer screening works only when image acquisition, interpretation, reporting and communication all function correctly. A technically excellent image that is never communicated to the patient represents one failure; an on-time report based on inadequate images represents another.
The FDA’s safety notification shows why quality regulation covers the entire chain.
For potentially affected patients, the message is deliberately practical rather than alarming: determine whether you have had a newer certified mammogram, obtain your records if necessary and let another qualified mammography facility decide whether the earlier images need to be repeated or investigated further.
