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U.S. Department of Health and Human Services

Medical Devices

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FDA Safety Notification: Mammography Problems at Med Pro Imaging in Plantation, Florida

 

Date Issued: August 17, 2010
 
Audience: 
  • Patients who had a mammogram at Med Pro Imaging facility in Plantation, Florida between May 21, 2008 and Sept. 30, 2009.
  • Health care providers who have referred patients to Med Pro Imaging facility for a mammogram performed between May 21, 2008 and Sept. 30, 2009.
 
Medical Specialty: Primary Care, Oncology, Radiation
 
Product:
A mammogram is a safe, low-dose X-ray picture of the breast. It is currently the most effective method of detecting breast cancer in its earliest, most treatable stages.
 
Summary of Problem or Scope:
The FDA has become aware of problems associated with the quality of mammograms performed at the Med Pro Imaging facility, formerly located at the following address:
 
7050 NW 4th Street, Suite #202
Plantation, Fla. 33317
 
Med Pro is under new management and is operating as Rivero Diagnostic Center, located at the same address.
 
The FDA worked with the American College of Radiology as they initiated a review of a sample of mammograms performed by Med Pro Imaging that included images taken between May 21, 2008 and Sept. 30, 2009. Results from that review included poor quality mammograms with unreliable results. Under the Mammography Quality Standards Act (MQSA) of 1992, the FDA requires that all mammography facilities meet certain high quality standards. This facility did not meet standards for mammography quality under that Act.
 
The FDA is alerting patients who had mammograms at this facility between May 21, 2008 and Sept. 30, 2009 about possible problems with the quality of mammograms performed. This does not mean that the results of all of the examinations were inaccurate. It does mean that patients might need to have their mammograms re-evaluated and possibly repeated.
 
Recommendations/Actions: 
The FDA recommends the following for patients who had a mammogram at Med Pro Imaging facility between May 21, 2008 and Sept. 30, 2009:
  • If you have had a mammogram at another facility since then, you should follow the recommendations from the latest mammogram.
  • If you have not had a mammogram at another facility since then follow these guidelines:
    • Talk with your current health care provider as soon as possible about a medical follow-up.
    • To request a copy of your mammogram performed by Med Pro Imaging, call or e-mail Rivero Diagnostic Center at (954) 791-9729 or MyExam@rdcimaging.com. You can also complete a record request form online at http://www.rdcimaging.com/index.php?p=1_19 or fax the form to (954) 791-9724.
    • If Rivero Diagnostic Center cannot provide you with a copy of your mammogram performed by Med Pro Imaging, you can request your patient records by contacting Iron Mountain located in Sunrise, Florida at 1-800-899-4766 or online at http://www.ironmountain.com/services/request-medical-records.html.
    • If your health care provider wants you to have another mammogram, it should be done at a MQSA-certified facility to ensure quality and accuracy. A list of MQSA-certified facilities is available online at http://www.fda.gov/CDRH/MAMMOGRAPHY/certified.html.
    • If your health insurance will not pay for a repeat mammogram, you can call the National Cancer Institute’s (NCI) information number at 1-800-422-6237 for a listing of facilities near you that will provide free or low- cost mammograms.  
 
Health care providers who have not been contacted by the FDA but believe that one or more of their patients had a mammogram at this facility during the time period in question can contact Rivero Medical Center at (954) 791-9729 or MyExam@rdcimaging.com for further patient information.
 
FDA Activities: 
The agency will continue to monitor this problem and keep the public informed as new information becomes available.
 
This safety alert is in keeping with FDA’s commitment to inform the public about safety issues. 
 
Contact Information:
If you have questions about this communication, please contact the MQSA Hotline at 1-800-838-7715, email your question to MQSAhotline@hcmsllc.com or fax to 1-410-290-6351.

 

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