FDA Device recall Z-2301-2013
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system gene…
- FDA Device
- Class II
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class II recall of Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system gene… by Hologic, citing software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2301-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-06 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hologic |
| Distribution | AL, AR, CA, CO, FL, IL, KY, LA, NC, NE, NJ, NY, OH, PA, TN, TX, UT, WA, WV |
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
Identifiers
| code_info | Software versions 5.0.x and 5.1.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2301-2013%22
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