Recall Z-2301-2013— Hologic, Inc.
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc., initiated 2013-09-06, terminated 2013-12-13. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images.
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-06
- Terminated
- 2013-12-13
- Firm location
- Danbury, CT, United States
Product 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
Reason for recall
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Data sourced from openFDA. This site is unofficial and independent of the FDA.