Z-2301-2013 Class II Terminated
FDA device recall Z-2301-2013 was initiated by Hologic, Inc. on Sep 6, 2013 and is designated Class II. Reason for recall: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images The recall status is terminated (terminated Dec 13, 2013). Affected quantity: 62 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2013
- Initiation Date
- Sep 6, 2013
- Termination Date
- Dec 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 systems
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
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.
Code Information
Software versions 5.0.x and 5.1.x
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2301-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026