FirstAlerts

FDA Reports Injuries in Ongoing Mammography Center of Monterey Quality Case

The agency has received reports of injuries or illnesses tied to the center's image quality problems, though it has not determined any cancer was missed.

3 reports on this incident · first at Sep 1, 2026, 7:15 a.m. ET

By AI ReporterFirst reported Sep 1, 2026, 6:30 a.m. ETWritten Sep 1, 2026, 7:52 a.m. ET
The FDA has received reports of injuries or illnesses in connection with image quality problems at the , according to Medical Daily. The agency has not said any cancer was missed, and no such determination has been published. The FDA's safety notification, reported by Medical Daily, says The agency is advising patients to request their images and reports from the Monterey center and have them reviewed at another certified facility to decide whether a repeat mammogram or further follow-up is needed. The status of the agency's action is , Medical Daily reported.

Earlier reports

  1. Sep 1, 2026, 7:22 a.m. ET

    FDA Closes Action on Monterey Mammography Center Over Image Quality

    The U.S. Food and Drug Administration has closed its action against the Mammography Center of Monterey, meaning the agency considers the recall carried out, according to Medical Daily.

    The action stemmed from a safety notification over severe image quality problems that could cause a mammogram to miss a finding that a properly performed exam would have caught. The FDA has not said any cancer was missed, and no such determination has been published.

    The FDA notice does not provide any identifying codes, such as model numbers or lot numbers, so patients who had mammograms at the Monterey center should not assume they are not affected. The agency had advised patients to request their images and reports from the Monterey center and have them reviewed at another certified facility to decide whether a repeat mammogram or further follow-up is needed. The status of the action is ongoing, according to Medical Daily.

  2. Sep 1, 2026, 7:15 a.m. ETFirst report

    FDA Warns of Image Quality Problems at Monterey Mammography Center

    The U.S. Food and Drug Administration (FDA) has issued a safety notification regarding the Mammography Center of Monterey in Monterey Peninsula, according to a report by Medical Daily. The notification, published on September 1, 2026, warns that a mammogram with severe image quality problems can miss a finding that a properly performed exam would have caught.

    The FDA is advising patients who had mammograms at the center to request their images and reports and have them reviewed at another certified facility to decide whether a repeat mammogram or further follow-up is needed. The agency has not said any cancer was missed, and no such determination has been published.

    The status of the notification is ongoing, according to Medical Daily.

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Revision history

  1. Version 11 Sept 2026, 11:15current

    First published.

  2. Version 11 Sept 2026, 11:52current

    First published.

  3. Version 11 Sept 2026, 11:22current

    First published.

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