Radiation-Emitting Products

Mammography Facility Adverse Event and Action Report - January 8, 2014

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide.

In order to provide this information in the timeliest manner, we now post the following information in “real time,” as this action taken against a mammography facility has concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of Florida

Facility Name and Address:
All X Ray Diagnostic Services Corp.
4210 NW 4th Street
Miami, FL 33126-5427

Facility ID Number:
240972

Adverse Event:
On July 30, 2013, this facility was notified by the American College of Radiology (ACR) that it must participate in an Additional Mammography Review (AMR) due to serious image quality problems identified during the review of clinical images submitted for accreditation. On September 26, 2013, the ACR notified the facility that the problems found in the mammograms evaluated during its AMR revealed serious deficiencies involving the quality of mammography. As a result, the ACR revoked the facility’s application for accreditation effective October 2, 2013. The FDA evaluated information obtained from ACR concerning the reasons for the revocation of the facility's application for mammography accreditation. In addition, the facility’s provisional certification expired on October 2, 2013.

Action Taken:
Based on the serious image quality deficiencies noted during the AMR, the FDA required the facility perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients (and their providers) of the mammography image quality problems at the facility.

Corrective Action:
On January 8, 2014, the FDA notified the facility that it successfully completed the PPN process.

Status of the Facility:
The facility has ceased performing mammography.

Page Last Updated: 11/03/2014
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