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

Hologic sent an Urgent Medical Device Recall letter dated September 5, 2013, by Certified Mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised how to avoid loss of images until Hologic corrects the problem. A software upgrade to customers who are connected to Hologic Connect who have already been connected remotely and customers who have already been connected via a Service Call will receive notification of the problem and the date the system was remotely corrected notified by Certified Mail. A Dealer notification issued by certified mail to inform Dealers of the need to notify their customers of the problem and to correct the identified Selenia system using Hologic Technical Bulletin TB-00072. Selenia software version 5.2 will implement a double safeguard to both guarantee a 28 day retention period, as well as ensure images are removed in a least recently used order. If there are any questions regarding this field correction, please call Hologic Customer Support at 877 371-4372.