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Hologic, Inc. recalls Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital M
Recalled October 9, 2013 · FDA recall Z-2301-2013 · Hologic
Hazard
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images · FDA Class II
Units
62 systems
Sold at
Worldwide Distribution - USA including the states of AL, AR, CA, CO, FL, IL, KY, LA, NE, NC, NJ, NY, OH, PA, TN, TX, UT, WA and WV., and the countries of Canada, Denmark, Iran, Italy, Mexico and Taiwan.
Description
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Product
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
Manufacturer(s)
Hologic, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →