Device 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
Z-2301-2013
Product summary
- Firm
- Hologic, Inc.
- Event
- Event 66195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 systems
- Official record key
device-enforcement:Z-2301-2013
Official wording
Reason: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Code information: Software versions 5.0.x and 5.1.x
Distribution pattern: 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.
Derived failure modes
-
Device software or design
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may