FDAFDA · Food and drugs·Recall number Z-2301-2013
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
Published October 9, 2013 · Recall initiated: September 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hologic, Inc.
- Distributor
- 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.
- Lot
- Software versions 5.0.x and 5.1.x
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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