FDA напрямую предупредила пациенток калифорнийской клиники, игнорирующей требование о повторном обследовании

California Imaging Center Failed a Federal Image Review and Never Warned the Patients Regulators Ordered It to Contact Federal regulators have gone directly to patients with a warning that a California breast imaging center was supposed to deliver itself. The Food and Drug Administration issued a safety notification on August 28, alerting anyone who had a mammogram at the Mammography Center of Monterey on or after December 22, 2023, that there may be problems with the quality of those exams. The reason the agency is doing the notifying is the part that matters most. On June 22, the FDA ordered the facility to contact at-risk patients and their referring providers. As of the posting of the safety notification, the agency states the facility has not complied with that order. For a woman on the Monterey Peninsula who had a screening mammogram in the past two and a half years and heard nothing afterward, the practical situation is now this: the exam that was supposed to rule out breast cancer may not have been reliable, and no one from the clinic is going to call. A Clinic That Lost Its Certificate More Than Eight Months Ago The failure chain is documented in the notification, and it runs back nearly a year. The American College of Radiology, the facility's accreditation body, and the FDA received multiple consumer complaints alleging that the center failed to give written mammography reports to health care providers and written lay summaries to patients within 30 days of the exam. Complaints also alleged the facility failed to transfer mammography records within 15 days of a request. On October 31, 2025, the ACR told the facility to submit a letter of corrective action. The facility did not respond adequately. The ACR notified it of its intent to revoke accreditation on December 10, 2025, offered an appeal window closing December 15, received no appeal, and revoked accreditation on December 17. An FDA inspection the day before confirmed the facility had failed to communicate results to some patients and providers within 30 calendar days. On December 22, 2025, the FDA placed the center's certificate under the Mammography Quality Standards Act into a status of no longer in effect. The facility may not legally perform mammography and is not currently accredited. The Review That Turned a Paperwork Problem into an Imaging Problem Late reports are a serious failure on their own. A woman waiting on a result is not being screened; she is waiting. But the FDA ordered a further step called an Additional Mammography Review, performed by the ACR, to determine whether the overall quality of the imaging had been compromised and whether patients needed to be told. The ACR issued that report to the facility on June 11. The facility failed the review, and the notification states that some clinical image quality deficiencies were severe. That is the finding that turns this from an administrative enforcement story into a clinical one. A mammogram with severe image quality problems can miss a finding that a properly performed exam would have caught. The FDA does not say any cancer was missed, and no such determination has been published. The agency's guidance is measured rather than alarming. If you have had a mammogram at a different certified facility since December 22, 2023, follow that facility's recommendations. If you have not, the FDA suggests requesting your images and reports from the Monterey center and having them reviewed at another certified facility to decide whether a repeat mammogram or further follow-up is needed. The Records Are the Obstacle, and Patients Have a Right to Them The awkward part of that advice is that it requires cooperation from a clinic that has already failed to respond to its accreditor, its regulator, and a direct federal order. Patients have a legal right to their mammograms and reports, and the FDA states plainly that patients or their representatives may request them. The agency's current recommendation is that patients contact the Mammography Center of Monterey at 798 Cass Street, Suite 205, to gain access to their medical records. If that goes nowhere, there is a federal line to call. The FDA has published its Mammography Quality Standards Act hotline at 1-800-838-7715 for questions about this notification. Patients can also use the agency's certified facility database to find an accredited center nearby, or call the National Cancer Institute at 1-800-422-6237. Cost is a reasonable question to raise early rather than after the fact. Anyone arranging a review or a repeat exam can ask the new imaging center's billing office how the visit will be coded and ask their insurer what it will cover, before scheduling. Monterey County residents who are uninsured or underinsured can ask about California's Every Woman Counts program, which provides free breast and cervical cancer screening and diagnostic services to eligible low-income residents. An Open Enforcement File with No Deadline Attached Several things remain unresolved, and readers should know which is which. Confirmed: the accreditation revocation, the certificate status, the failed image review, the order to notify patients, and the facility's noncompliance with that order as of the notification date. Not established: whether any patient's cancer diagnosis was delayed, how many patients fall inside the at-risk window, and whether the facility will ever perform the notification itself. The FDA says it will continue to monitor the situation and keep the public informed, and posts updates through its reports and safety notifications index. The facility is required to submit an extensive corrective action plan to the ACR. No date has been announced for a decision on that plan, and no enforcement penalty against the facility has been made public. MedicalDaily will report any patient notification the facility issues, any change in its certificate status, and any further federal action. The reasonable step for anyone affected is small and specific. Check whether your mammogram since late December 2023 was done at this Monterey address, and if it was, get the images reviewed somewhere accredited before your next scheduled screening rather than after it. Screening still works. This is a problem with one facility, not with mammography. Key Questions Answered Who is affected? Anyone who had a mammogram at the Mammography Center of Monterey in Monterey, California, on or after December 22, 2023. What went wrong? The facility failed to deliver results within 30 days, lost its accreditation, and later failed an independent image quality review in which some deficiencies were severe. Why is the FDA notifying patients directly? The agency ordered the facility to notify at-risk patients in June. It says the facility has not complied. Does everyone need a repeat mammogram? No. The FDA suggests having prior images reviewed at a certified facility to decide whether a repeat exam or further follow-up is needed. Has a missed cancer been confirmed? No. The agency has not reported any missed diagnoses. The concern is that the exams may not be reliable. Can the facility still perform mammograms? No. Its MQSA certificate is not in effect, and it is not accredited, so it may not legally perform mammography. Where can patients get help? The FDA's Mammography Quality Standards Act hotline at 1-800-838-7715, or the National Cancer Institute at 1-800-422-6237, to locate a certified facility. Published by Medicaldaily.com