In February, the American College of Radiology (ACR) started an additional review of mammograms performed at Lakes Radiology II, due to deficiencies it found during an initial accreditation process for a second mammography device. In April, the ACR notified the FDA and the facility that this additional review showed that the center's mammograms were not of sufficient image quality, and it revoked its accreditation.
The FDA declared the center's Mammography Quality Standards Act (MQSA) certificate to no longer be in effect and asked Lakes Radiology II to alert all patients and providers of the image problems.
The center accomplished this by August 16. Its accreditation has been reinstated, it has been reissued an MQSA certificate, and it is performing mammography, the agency said.
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