Hologic, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2301-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 6, 2013

Date Posted: October 9, 2013

Recall Number: Z-2301-2013

Event ID: 66195

Reason for Recall:

Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images

Status: Terminated

Product Quantity: 62 systems

Code Information:

Software versions 5.0.x and 5.1.x

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated