FDA Warns Monterey Mammography Patients May Need Repeat Imaging After Accreditation Revoked

FDA warns patients who had mammograms at Mammography Center of Monterey on/after Dec 22, 2023 to have their information reviewed by another certified facility; severe image quality deficiencies and report delays led ACR to revoke accreditation.

• FDA says the center failed to provide mammography reports and written lay summaries to patients within 30 days, and did not transfer records within 15 days of request.
• The ACR revoked the facility's accreditation in December after an image review found severe clinical image quality deficiencies; MCM cannot legally perform mammography until further notice.
• The center has not complied with a June 22 Patient and Provider Notification order, and FDA urges affected patients to seek review at another certified facility.

Automated summary

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