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
Enforcement
- Recall Number
- Z-2301-2013
- Event ID
- 66195
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hologic, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 9, 2013
- Initiation Date
- September 6, 2013
- Classification Date
- September 30, 2013
- Termination Date
- December 13, 2013
- Address
- 36 Apple Ridge Rd # 37, Danbury, CT, 06810-7301, United States
Description
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
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Software versions 5.0.x and 5.1.x
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.
62 systems