The FDA issued a warning on Monday that there may be possible problems with the quality of the mammograms performed at Big Sky Diagnostic Imaging, LLC in Montana. The statement came after the agency worked with the American College of Radiology (ACR), when it did a routine review of a sample of mammograms done at the facility from November 20, 2011 to November 20, 2013.

Although the FDA said that it does not mean that the exams were inaccurate, it is recommending that the patients speak with their health care providers to determine if they should get a follow-up mammogram.

Facilities are required by the Mammography Quality Standards Act (MQSA) to comply with baseline quality standards and be certified to legally operate in the U.S., and the FDA stated that the facility did not meet the requirements. The ACR revoked its accreditation and its MQSA certification is not valid anymore.The facility has not performed mammography since February 6, 2014.

The ACR was contacted, but stated that it is not in a position to comment on facility-related accreditation matters.

Dr. Jesse Cole, owner of the facility, spoke with DOTmed News and claimed that the culprit may be the mammography system that his facility used. He said that even though he gets the machine inspected by a physicist every year and it passes the tests, it still might be working incorrectly.

"We think that this machine may be functionally obsolete for certain people and we think the FDA should investigate that," he said. "We've gone through a great deal of trouble and expense and worry to find out what the problem was and what we discovered is that it isn't us, although we seem to be getting painted with that brush."

He said that the FDA found issues with the way the patients were positioned, the machine function, the degree of compression and his readings. But he said that about 50 percent of the problems were with the machine function, including sharpness, contrast, and density, and he said that is not something that he controls.

"It's like buying a camera, it's built into the functionality of it - we don't have a button to adjust," he added.

He is now having the patients go to the Community Hospital in Anaconda, Montana so that he can perform repeat mammograms and ultrasounds, in some cases. He said that they are about halfway through the patients and have not found any problems yet.

He is also asking the patients to sign complaint letters regarding the mammography system so that he can present it to the FDA, and he said that they have been cooperative in signing the letters.

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