FDA updates adverse event report for NY mammo facility

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has updated an adverse event report it issued for South Shore Radiology of Howard Beach, NY.

Last August, the American College of Radiology (ACR) initiated an additional review of the facility's mammograms because it was using an unaccredited digital breast tomosynthesis (DBT) unit to image patients. In September, the ACR notified the FDA and South Shore Radiology that the review revealed serious deficiencies in image quality; in October, the organization revoked the center's mammography accreditation.

The FDA required South Shore Radiology to notify its patients and healthcare providers about the deficiencies, which it completed in January. The facility's accreditation has been reinstated and it is performing mammography again, the FDA said.

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