Company:Hologic Inc.
Date of Enforcement Report: 10/9/2013
Class ll:
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 mammograph. Recall Number Z-2301-2013
REASON
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
RECALLING FIRM/MANUFACTURER
Hologic, Inc, Danbury, CT on 9/6/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
62 systems
DISTRIBUTION
Nationwide and Internationally
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