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Mammography Facility Adverse Event and Action Report - May 24, 2018 (Updated March 08, 2019): Magnetic Resonance of New Jersey

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 actions taken against mammography facilities are concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of New Jersey

Facility Name and Address:

Magnetic Resonance of New Jersey
410 Centre Street
Nultey, NJ 07110

Facility ID Number:

241797

Adverse Event:

On April 18, 2018, an MQSA inspector from the State of New Jersey's Bureau of X-ray Compliance performed an MQSA inspection at the facility after the inspector determined that the facility was providing mammography services without having a valid MQSA certificate.

Action Taken:

The inspection revealed that the facility's MQSA certified expired on March 11, 2018. The facility continued to provided mammography services after the expiration of the facility's MQSA certificate and was cited for the violation. A facility that does not have a valid MQSA certificate cannot legally perform mammography services.

Because the facility operated uncertified, the Food and Drug Administration (FDA) required the facility to undergo a limited Additional Mammography Review (AMR) conducted by the American College of Radiology (ACR).

The ACR notified the FDA and the facility that the AMR revealed deficiencies with clinical image quality and images did not meet the ACR’s clinical image evaluation criteria. The FDA ordered the facility to submit additional images to the ACR for an expanded mammography review. To date, neither the FDA nor the ACR has received the requested images for the expanded additional image review.

Corrective Action:

On April 24, 2018, the State of New Jersey issued an Administrative Order to the facility stating the facility shall cease operations or comply in accordance with the regulations within thirty (30) days.

On April 24, 2018, the State of New Jersey issued a Notice of Prosecution to the facility stating that the offer of settlement based upon the facility's violations is $1,000 to be paid to the Treasurer, State of New Jersey within thirty (30) days.

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

The facility successfully completed the PPN and was notified of such by the FDA on February 8, 2019.

Status of the Facility:

The facility is currently not performing mammography.

Page Last Updated: 03/11/2019
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